Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116246
Status:
UNKNOWN
Last Update Posted:
2006-09-08
First Post:
2005-06-27
Brief Title:
McRoberts Manoeuvre Or Pushing Study McMOPS
Sponsor:
University of Melbourne
Organization:
University of Melbourne
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
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:
None
Brief Summary:
We propose to conduct a randomised-controlled study to investigate whether adopting McRoberts position after 45 minutes of active pushing with no signs of progress can increase the probability of vaginal delivery preventing the need for forceps or vacuum assistance In our study we will allow 45 minutes of pushing before a further 45 minutes of either the same or our intervention McRoberts manoeuvre
Detailed Description:
When women are in labour they firstly undergo the first stage of labour where the cervix neck of the womb progresses to full dilatation Once this occurs they have reached the second stage where the mother can start pushing to deliver the baby It is accepted practice to allow mothers to actively push for a maximum of one hour
In most cases the baby will deliver spontaneously However in about 30 of cases of those who manage to labour to the second stage fully dilated cervix the obstetrician will have to assist delivery by the use of forceps or vacuum extraction instrumental delivery There are two main situations where delivery needs assistance fetal distress where the baby is suspected to be compromised or failure to progress where the baby has not delivered after one hour of pushing Unfortunately instrumental delivery is associated with increased maternal and fetal problems particularly arising from trauma to the tissues Therefore the identification of any new ways to increase the spontaneous delivery rate may decrease future complications
Shoulder dystocia is a rare but dangerous scenario where the babys head is delivered but the shoulders are trapped behind the pubic bones The McRoberts position is used in this situation to deliver the baby The mothers legs are flexed and pushed up and out lateral to her abdomen It is believed that this helps by flattening out the sacral bone tail bone thereby widening the bony opening and allowing the shoulders to become free
A recent paper 1 reported the novel finding that McRoberts position also doubled the pressure generated by contractions compared to normal pushing The authors believed that this increase in pressure was caused by the fact that the uterus was brought closer to the diaphragm that provides the power generated with pushing
Our group wondered whether this substantial increase in pressure could be harnessed beyond the rare setting of shoulder dystocia We therefore propose to conduct a randomised-controlled study to investigate whether adopting McRoberts position after 45 minutes of active pushing with no signs of progress can increase the probability of vaginal delivery preventing the need for forceps or vacuum assistance Studies have shown that after one hour of active pushing the fetus shows signs of increasing distress In our study we will allow 45 minutes of pushing before a further 45 minutes of either the same or our intervention McRoberts manoeuvre
Women in their first pregnancy will be approached at 36 weeks in the antenatal clinic and advised of our study in the form of written information The majority of women will not be approached again since they will not be relevant to this study most having already delivered However women who have been pushing for 45 minutes will be invited to participate in the study
The second stage of labour is a demanding process where it may not be practicable to obtain written consent Therefore having given information about the trial at their 36 week antenatal visit we will enrol women after obtaining informed verbal consent They will be specifically asked whether they have read and understood the prior information given to them at clinic
Those consenting will be randomised to either continue in their current position or be placed in McRoberts position The woman will be allowed to push for a further 45 minutes After this time women in both groups who have not yet delivered will be aided by instrumental delivery if deemed necessary A few days after delivery we will provide women with a questionnaire to determine patient satisfaction and how well they tolerated the procedure they ended up having ie Operative delivery or McRoberts position
We hope to find a significant reduction in the number of instrumental deliveries in the group of women placed in McRoberts position as compared with the other group A positive finding may be immediately and widely applicable
References
1 Catalin SB et al Use of McRoberts position during delivery and increase in pushing efficiency The Lancet 2001 358 470-471
2 Nordstrom L et al Fetal and maternal lactate increase during active second stage of labour British Journal of Obstetrics and Gynaecology 2001 108263-268
In most cases the baby will deliver spontaneously However in about 30 of cases of those who manage to labour to the second stage fully dilated cervix the obstetrician will have to assist delivery by the use of forceps or vacuum extraction instrumental delivery There are two main situations where delivery needs assistance fetal distress where the baby is suspected to be compromised or failure to progress where the baby has not delivered after one hour of pushing Unfortunately instrumental delivery is associated with increased maternal and fetal problems particularly arising from trauma to the tissues Therefore the identification of any new ways to increase the spontaneous delivery rate may decrease future complications
Shoulder dystocia is a rare but dangerous scenario where the babys head is delivered but the shoulders are trapped behind the pubic bones The McRoberts position is used in this situation to deliver the baby The mothers legs are flexed and pushed up and out lateral to her abdomen It is believed that this helps by flattening out the sacral bone tail bone thereby widening the bony opening and allowing the shoulders to become free
A recent paper 1 reported the novel finding that McRoberts position also doubled the pressure generated by contractions compared to normal pushing The authors believed that this increase in pressure was caused by the fact that the uterus was brought closer to the diaphragm that provides the power generated with pushing
Our group wondered whether this substantial increase in pressure could be harnessed beyond the rare setting of shoulder dystocia We therefore propose to conduct a randomised-controlled study to investigate whether adopting McRoberts position after 45 minutes of active pushing with no signs of progress can increase the probability of vaginal delivery preventing the need for forceps or vacuum assistance Studies have shown that after one hour of active pushing the fetus shows signs of increasing distress In our study we will allow 45 minutes of pushing before a further 45 minutes of either the same or our intervention McRoberts manoeuvre
Women in their first pregnancy will be approached at 36 weeks in the antenatal clinic and advised of our study in the form of written information The majority of women will not be approached again since they will not be relevant to this study most having already delivered However women who have been pushing for 45 minutes will be invited to participate in the study
The second stage of labour is a demanding process where it may not be practicable to obtain written consent Therefore having given information about the trial at their 36 week antenatal visit we will enrol women after obtaining informed verbal consent They will be specifically asked whether they have read and understood the prior information given to them at clinic
Those consenting will be randomised to either continue in their current position or be placed in McRoberts position The woman will be allowed to push for a further 45 minutes After this time women in both groups who have not yet delivered will be aided by instrumental delivery if deemed necessary A few days after delivery we will provide women with a questionnaire to determine patient satisfaction and how well they tolerated the procedure they ended up having ie Operative delivery or McRoberts position
We hope to find a significant reduction in the number of instrumental deliveries in the group of women placed in McRoberts position as compared with the other group A positive finding may be immediately and widely applicable
References
1 Catalin SB et al Use of McRoberts position during delivery and increase in pushing efficiency The Lancet 2001 358 470-471
2 Nordstrom L et al Fetal and maternal lactate increase during active second stage of labour British Journal of Obstetrics and Gynaecology 2001 108263-268
Study Oversight
Has Oversight DMC:
None
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?:
None