Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-02 @ 10:47 PM
Study NCT ID:
NCT03389958
Status:
COMPLETED
Last Update Posted:
2018-01-04
First Post:
2017-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternity Care and Contraception
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
Safe Maternity Care Through Immediate Provision of Highly-effective Postpartum Contraception
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMSE
Brief Summary:
This is a multicenter observational study of implementation of postpartum contraceptive counseling and provision into the maternity care setting in Colombia, South America. The primary aim is to determine proportion of uptake of highly-effective contraceptive use after these methods become available immediately postpartum. Secondary aims include rapid repeat pregnancy rates, use of other types of contraception, breastfeeding continuation, and visualization of IUD strings after immediate postpartum placement.
Detailed Description:
This pre- post-intervention study will take place in Colombia, South America in 2 cities: Medellin (2 sites and Cartagena 1 site). The main objective is to determine the proportion of contraceptive usage by women who have just had a baby, before and after the introduction of specialized contraceptive counseling into maternity care and availability of the most effective contraceptive methods:
Group 1 (Standard of care) participants will be asked about intention for contraception usage upon hospital discharge after maternity care.
Group 2 (Intervention) participants will receive standardized contraceptive counseling and immediate access to the method of choice, including long acting reversible contraception (LARC) and other locally available methods. LARC methods available in Colombia include the copper-T intrauterine device (IUD) and Jadelle® implant, both of which are safe for usage in postpartum women.
Both groups will undergo follow- up via phone at 6-8 weeks, and 6 and 12 months postpartum to determine contraceptive continuation, repeat pregnancy, and to track any complications with the usage of LARC, including infection and contraceptive failure. For subjects with an IUD, an additional visit would take place at 8-10 days to determine need for IUD string trimming and visualization of strings.
The intervention will include introduction of specialized standardized contraceptive counseling to occur during inpatient maternity care and immediate postpartum availability of LARC methods. Currently, contraceptive counseling is left to the postpartum primary care setting and obstetric providers are not trained for immediate IUD placement. LARC devices are not typically available in the inpatient setting. Providers and staff of all levels will be trained in standardized contraceptive counseling methods. Obstetric providers will be trained in immediate postplacental IUD insertion. Staff nurses and providers will have access to company-sponsored implant insertion training programs.
The proportion of participants using LARC methods after implementation of the intervention will be compared to the proportion choosing LARC prior to the intervention. Additionally, the outcomes of women choosing non-LARC methods will be compared to those choosing LARC methods.
The study has received funding by the Colombian grant agency, Colciencias. Regulatory oversight has previously been granted by the University of Antioquia's (Medellin, Colombia) Institutional Review Board. Research operations are managed by the local Colombian organization, NACER, with support of research design and methods, statistical analysis, and medical expertise and trainings provided by clinicians from OHSU. Day to day research operations will be managed by research coordinators at each of the three maternity care hospital sites with support and monitoring by NACER and by OHSU clinicians.
The role of OHSU clinicians will be to provide research infrastructure and clinical support via remote communications, to provide initial training of trainers, to provide monitoring of recruitment and counseling methods, to help in the creation and monitor quality of data collection forms, and to perform statistical analyses. OHSU will not participate in recruitment of participants or in clinical procedures. We do not plan to be present at any research sites in person, though may perform monitoring visits if funds are available.
Group 1 (Standard of care) participants will be asked about intention for contraception usage upon hospital discharge after maternity care.
Group 2 (Intervention) participants will receive standardized contraceptive counseling and immediate access to the method of choice, including long acting reversible contraception (LARC) and other locally available methods. LARC methods available in Colombia include the copper-T intrauterine device (IUD) and Jadelle® implant, both of which are safe for usage in postpartum women.
Both groups will undergo follow- up via phone at 6-8 weeks, and 6 and 12 months postpartum to determine contraceptive continuation, repeat pregnancy, and to track any complications with the usage of LARC, including infection and contraceptive failure. For subjects with an IUD, an additional visit would take place at 8-10 days to determine need for IUD string trimming and visualization of strings.
The intervention will include introduction of specialized standardized contraceptive counseling to occur during inpatient maternity care and immediate postpartum availability of LARC methods. Currently, contraceptive counseling is left to the postpartum primary care setting and obstetric providers are not trained for immediate IUD placement. LARC devices are not typically available in the inpatient setting. Providers and staff of all levels will be trained in standardized contraceptive counseling methods. Obstetric providers will be trained in immediate postplacental IUD insertion. Staff nurses and providers will have access to company-sponsored implant insertion training programs.
The proportion of participants using LARC methods after implementation of the intervention will be compared to the proportion choosing LARC prior to the intervention. Additionally, the outcomes of women choosing non-LARC methods will be compared to those choosing LARC methods.
The study has received funding by the Colombian grant agency, Colciencias. Regulatory oversight has previously been granted by the University of Antioquia's (Medellin, Colombia) Institutional Review Board. Research operations are managed by the local Colombian organization, NACER, with support of research design and methods, statistical analysis, and medical expertise and trainings provided by clinicians from OHSU. Day to day research operations will be managed by research coordinators at each of the three maternity care hospital sites with support and monitoring by NACER and by OHSU clinicians.
The role of OHSU clinicians will be to provide research infrastructure and clinical support via remote communications, to provide initial training of trainers, to provide monitoring of recruitment and counseling methods, to help in the creation and monitor quality of data collection forms, and to perform statistical analyses. OHSU will not participate in recruitment of participants or in clinical procedures. We do not plan to be present at any research sites in person, though may perform monitoring visits if funds are available.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: