Clinical trial NCT03517696: Membrane Sweeping in Early Labor and Delivery Outcomes
Official title: Membrane Sweeping in Early Labor and Delivery Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Early Labor
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-05-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-blinded Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decrease in Cesarean delivery rate
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Time to delivery
timeFrame: Up to 3 weeks
measure: Operative vaginal delivery rate
timeFrame: Up to 3 weeks
measure: Labor augmentation rate reduction
timeFrame: Up to 3 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeanne S Sheffield, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 10.1097/aog.0b013e3182704880.
citation: ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
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.
citation: Boulvain M, Stan C, Irion O. Membrane sweeping for induction of labour. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD000451. doi: 10.1002/14651858.CD000451.pub2.
citation: Foong LC, Vanaja K, Tan G, Chua S. Membrane sweeping in conjunction with labor induction. Obstet Gynecol. 2000 Oct;96(4):539-42. doi: 10.1016/s0029-7844(00)00995-9.
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. doi: 10.1097/01.AOG.0000200094.89388.70.
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.
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.