Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-02 @ 6:26 PM
Study NCT ID:
NCT02944656
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2016-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tiffany.p.hailstorks@emory.edu', 'phone': '404-778-1385', 'title': 'Tiffany Hailstorks, MD, MPH', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Data on adverse events were collected from the time of investigational medication administration through the follow up phone call on the day after the procedure.', 'description': 'In addition to specific side effects collected as an outcome measure, adverse effects were tracked and monitored during the study. An adverse event is defined as any health-related reaction, effect, toxicity or abnormal laboratory result experienced during the course of the study, irrespective of relationship to the study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 1, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 1, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Low Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased nausea and vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain at Time of Uterine Evacuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'title': 'Paracervical block', 'categories': [{'measurements': [{'value': '63.79', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '62.21', 'spread': '3.52', 'groupId': 'OG001'}]}]}, {'title': 'Dilation', 'categories': [{'measurements': [{'value': '64.58', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '66.12', 'spread': '3.54', 'groupId': 'OG001'}]}]}, {'title': 'Aspiration', 'categories': [{'measurements': [{'value': '67.77', 'spread': '3.63', 'groupId': 'OG000'}, {'value': '71.06', 'spread': '3.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the procedure on Study Day 1', 'description': 'The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing all assessments on the day of the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Perioperative Pain Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'title': 'Prior to procedure', 'categories': [{'measurements': [{'value': '20.76', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '22.48', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'Speculum removal', 'categories': [{'measurements': [{'value': '44.10', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '47.61', 'spread': '3.52', 'groupId': 'OG001'}]}]}, {'title': '10 minutes post-procedure', 'categories': [{'measurements': [{'value': '30.64', 'spread': '3.65', 'groupId': 'OG000'}, {'value': '43.68', 'spread': '3.47', 'groupId': 'OG001'}]}]}, {'title': '30 minutes post-procedure', 'categories': [{'measurements': [{'value': '20.89', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '31.65', 'spread': '3.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing all assessments on the day of the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Pain Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative Day 1', 'description': 'The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the follow up assessment one day after the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Perioperative Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'title': 'Prior to procedure', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '57'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '59'}]}]}, {'title': '10 minutes post-procedure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '22'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '52'}]}]}, {'title': '30 minutes post-procedure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '16'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while "worst nausea I have ever felt" is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing all assessments on the day of the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Perioperative Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'title': 'Prior to procedure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '10 minutes post-procedure', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '30 minutes post-procedure', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing all assessments on the day of the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Anxiety Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'title': 'Prior to procedure', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '83'}, {'value': '72', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '96.5'}]}]}, {'title': '10 minutes post-procedure', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '36'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '49'}]}]}, {'title': '30 minutes post-procedure', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '29'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Participants reported how much anxiety they were currently experiencing on a 100-point scale where "No Anxiety" is scored as 0 and "Extremely Anxious" is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing all assessments on the day of the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'title': 'Dizziness 10 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness 30 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Lack of muscle control 10 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Lack of muscle control 30 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness/drowsiness 10 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Sleepiness/drowsiness 30 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Weakness 10 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Weakness 30 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Headache 10 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Headache 30 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Vision changes 10 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Vision changes 30 minutes post-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 and 30 minutes post procedure on Study Day 1', 'description': 'Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes participants responding to the side effects questions. Two did not answer any questions. Two participants in the gabapentin group did not complete the side effect assessment at 30 minutes post-procedure. One participant in the placebo group did not respond to the assessment of weakness at 30 minutes post-procedure.'}, {'type': 'SECONDARY', 'title': 'Moderate Pain at Postoperation Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Moderate pain" was defined according to the perception of each participant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the follow up assessment one day after the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Severe Pain at Postoperation Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Severe pain" was defined according to the perception of each participant.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the follow up assessment one day after the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Nausea or Vomiting at Postoperation Follow-up Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the follow up assessment one day after the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Vomiting Since Leaving Clinic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'categories': [{'title': 'No vomiting', 'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}, {'title': 'Vomiting at least once', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the follow up assessment one day after the procedure are included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Overall Satisfaction With the Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'classes': [{'categories': [{'title': '1 (very dissatisfied)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '5', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '6', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': '7', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '8', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '9', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': '10 (very satisfied)', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Postoperative Day 1', 'description': 'Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing the follow up assessment one day after the procedure are included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Completed Procedure Day', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Completed Day 1 Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'No longer eligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}], 'recruitmentDetails': "Participants were recruited from the Atlanta Women's Center in Atlanta, Georgia. Enrollment began on December 8, 2016 and all study procedures concluded on June 26, 2018.", 'preAssignmentDetails': 'A total of 122 individuals were eligible and consented to participate in the study. Six withdrew prior to randomization and an additional 2 withdrew prior to beginning the study, resulting in 114 receiving the intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Gabapentin Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '26.01', 'spread': '5.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black/African American', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'White/Caucasian', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Mixed or multi-racial', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian/Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': "Don't know/Refused/Not Specified", 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '15.1', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '13.2', 'groupId': 'BG001'}, {'value': '61.3', 'spread': '14.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The baseline population includes participants completing all study procedures on the day of surgery.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-08', 'size': 519348, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-02T10:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2016-10-13', 'resultsFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2016-10-24', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-17', 'studyFirstPostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain at Time of Uterine Evacuation', 'timeFrame': 'During the procedure on Study Day 1', 'description': 'The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100.'}], 'secondaryOutcomes': [{'measure': 'Perioperative Pain Level', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge).'}, {'measure': 'Number of Participants Using Pain Medication', 'timeFrame': 'Postoperative Day 1', 'description': 'The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication.'}, {'measure': 'Perioperative Nausea', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while "worst nausea I have ever felt" is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.'}, {'measure': 'Perioperative Vomiting', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.'}, {'measure': 'Anxiety Levels', 'timeFrame': 'Pre-procedure through post-procedure on Study Day 1', 'description': 'Participants reported how much anxiety they were currently experiencing on a 100-point scale where "No Anxiety" is scored as 0 and "Extremely Anxious" is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure.'}, {'measure': 'Side Effects', 'timeFrame': '10 and 30 minutes post procedure on Study Day 1', 'description': 'Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes.'}, {'measure': 'Moderate Pain at Postoperation Follow-up Assessment', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Moderate pain" was defined according to the perception of each participant.'}, {'measure': 'Severe Pain at Postoperation Follow-up Assessment', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Severe pain" was defined according to the perception of each participant.'}, {'measure': 'Nausea or Vomiting at Postoperation Follow-up Assessment', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome.'}, {'measure': 'Vomiting Since Leaving Clinic', 'timeFrame': 'Postoperative Day 1', 'description': 'During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic.'}, {'measure': 'Overall Satisfaction With the Procedure', 'timeFrame': 'Postoperative Day 1', 'description': 'Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perioperative pain', 'Outpatient surgery', 'Obstetrics/gynecology', 'Pain management'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '32534843', 'type': 'DERIVED', 'citation': 'Hailstorks TP, Cordes SMD, Cwiak CA, Gray BA, Ge L, Moore RH, Haddad LB. Gabapentin as an adjunct to paracervical block for perioperative pain management for first-trimester uterine aspiration: a randomized controlled trial. Am J Obstet Gynecol. 2020 Dec;223(6):884.e1-884.e10. doi: 10.1016/j.ajog.2020.06.011. Epub 2020 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.', 'detailedDescription': 'Project Summary\n\nJustification for the project\n\nOne half of all pregnancies among American women are unintended, with nearly 4 in 10 ending in pregnancy termination by abortion. Elective abortions are among the most common outpatient surgical procedure, with an estimated 46 million performed worldwide annually. The management of pain is critical to patient care throughout the abortion experience since the vast majority of women will experience pain with the procedure. Patients are most affected by pain during paracervical block, cervical dilation, suction aspiration, and post operatively with uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention could impact thousands of women each year.\n\nProposed research\n\nThis is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.\n\nNew features\n\nGabapentin as an adjunct o pain management has proven beneficial in gynecological surgery. Its use in similar surgical settings as an adjunct to pain management regiments has proven to be beneficial. It is generally well tolerated, inexpensive, has minimal side effects, and few contraindications.\n\nProblems anticipated\n\nThe high volume at the study clinic will benefit recruitment efforts, however, as the coordination of this study may potentially disrupt clinic flow there will be limits on daily recruitment. Postoperative follow-up may be challenging, thus to reduce the impact of loss to follow-up, most of the outcomes are measured on the same day as the procedure. Further, multiple contact approaches will be employed and a second incentive offered after completion of the postoperative assessment.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women \\>=18 years-old\n* Presenting for a surgical abortion\n* Fluency in English and able to provide informed consent\n* Has a driver to take them home following the procedure\n\nExclusion Criteria:\n\n* Allergy, sensitivity or contraindication to gabapentin\n* Severe renal disease\n* Currently using gabapentin or pregabalin\n* Contraindication to outpatient abortion under local anesthesia'}, 'identificationModule': {'nctId': 'NCT02944656', 'acronym': 'Gaba', 'briefTitle': 'Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB00084198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin group', 'description': 'This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively.', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'This group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Gaba', 'Neurontin'], 'description': 'Participants in this group will receive 600 mg of gabapentin given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. Gabapentin is an FDA approved medication that is used to prevent seizures and to treat various forms of chronic and acute pain.', 'armGroupLabels': ['Gabapentin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants in this group will receive 600 mg of gelatin capsules that are identical in appearance to gabapentin capsules. The placebo will be given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Atlanta Women's Center", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Lisa Haddad, MD, MS, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Lisa Haddad', 'investigatorAffiliation': 'Emory University'}}}}