Membrane Sweeping in Early Labor and Delivery Outcomes

Early Labor Clinical Trial

Official title:

Membrane Sweeping in Early Labor and Delivery Outcomes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03517696
• Other study ID #: IRB00153394
• Status: Withdrawn
• Phase: N/A
• Start date: May 20, 2018
• Est. completion date: February 25, 2020

Study information

• Verified date: July 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. The goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.

Description:

This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score < 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.

Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.

Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.

No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.

Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.

Patients will be removed from the study if they chose to withdraw their participation.

Participants will resume care as normal regardless of withdrawing study participation.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, Bishop score <7, English or Spanish speaking

Exclusion Criteria:

• Prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping

Related Conditions & MeSH terms

• Early Labor
• Obstetric Labor, Premature

Intervention

Procedure:
• Membrane sweeping
Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise.

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (8)

ACOG Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-97. doi: 10.1097/AOG.0b013e3181b48ef5. Review. — View Citation

Al-Harmi J, Chibber R, Fouda M, Mohammed ZK, El-Saleh E, Tasneem A. Is membrane sweeping beneficial at the initiation of labor induction? J Matern Fetal Neonatal Med. 2015 Jul;28(10):1214-8. doi: 10.3109/14767058.2014.947951. Epub 2014 Aug 18. — View Citation

Berghella V, Baxter JK, Chauhan SP. Evidence-based labor and delivery management. Am J Obstet Gynecol. 2008 Nov;199(5):445-54. doi: 10.1016/j.ajog.2008.06.093. Review. — View Citation

Boulvain M, Stan C, Irion O. Membrane sweeping for induction of labour. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD000451. Review. Update in: Cochrane Database Syst Rev. 2020 Feb 27;2:CD000451. — View Citation

Chanrachakul B, Suthutvoravut S, Sangthawan M, Herabutya Y. Effect of lower uterine segment sweeping on progress of labor in nullipara. J Med Assoc Thai. 2001 Nov;84(11):1582-6. — View Citation

Foong LC, Vanaja K, Tan G, Chua S. Membrane sweeping in conjunction with labor induction. Obstet Gynecol. 2000 Oct;96(4):539-42. — View Citation

Spong CY, Berghella V, Wenstrom KD, Mercer BM, Saade GR. Preventing the first cesarean delivery: summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, and American College of Obstetricians and Gynecologists Workshop. Obstet Gynecol. 2012 Nov;120(5):1181-93. doi: http://10.1097/AOG.0b013e3182704880. — View Citation

Tan PC, Jacob R, Omar SZ. Membrane sweeping at initiation of formal labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Mar;107(3):569-77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Cesarean delivery rate	Decrease in Cesarean delivery rate	Up to 3 weeks
Secondary	Time to delivery	Length of labor from randomization to delivery	Up to 3 weeks
Secondary	Operative vaginal delivery rate	Assess a decrease in operative vaginal delivery	Up to 3 weeks
Secondary	Labor augmentation rate reduction	Assess the reduction in the rate of labor augmentation ( via the use of oxytocin and/or amniotomy)	Up to 3 weeks