PROphylactic Manual RotatIon in the Second stagE of Labor

Status Terminated

Clinical Trial Summary

This is a randomized controlled trial to determine whether prophylactic manual rotation for fetuses identified to have persistent occiput posterior or occiput transverse presentation (POP/OTP) at the initiation of the second stage of labor in nulliparous individuals reduces rates of operative delivery, second stage of labor duration, and resultant adverse clinical outcomes compared to standard management of the second stage of labor.

Clinical Trial Description

This is a randomized controlled trial in which nulliparous individuals with a term, singleton gestation who undergo a trial of labor with neuraxial anesthesia and have a fetus presenting with persistent occiput posterior or occiput transverse presentation (POP/OTP) confirmed by ultrasound at the initiation of the second stage of labor will be randomized to either prophylactic manual rotation or sham rotation. The study aims to evaluate whether prophylactic manual rotation reduces the incidence of operative delivery (a composite of cesarean and operative vaginal delivery), second stage of labor duration, and maternal and neonatal morbidity among nulliparous individuals with a fetus with POP/OTP at the initiation of the second stage of labor. Individuals will be screened for eligibility upon admission to Labor and Delivery and approached for potential recruitment with informed consent obtained on enrollment. Once women achieve complete cervical dilation and within the first fifteen minutes of commencement of pushing, a bedside ultrasound will be performed to determine the fetal position. Those with POP/OTP will be randomized at that time point to either prophylactic manual rotation or sham rotation. The patient's primary obstetrician will be blinded to the randomization arm. The electronic health record will be reviewed and used to assess trial outcomes. The study will enroll 350 individuals, powered to detect a 15% reduction in operative delivery (instrumental vaginal delivery or cesarean section) with prophylactic manual rotation of POP/OTP, from a baseline risk of 50% without manual rotation to 35% with prophylactic rotation at initiation of the second stage of labor. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05175040
Study type	Interventional
Source	Northwestern University
Contact
Status	Terminated
Phase	N/A
Start date	March 4, 2022
Completion date	December 15, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05017974` - Research on Improving Sleep During Pregnancy	N/A
Completed	`NCT03284515` - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting	`NCT05969795` - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support	Phase 1
Recruiting	`NCT06051201` - Innovation for Small-scale Experiments: ReceptIVFity Test	N/A
Recruiting	`NCT04828382` - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation	`NCT04527926` - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy	N/A
Recruiting	`NCT04278651` - Early Antenatal Support for Iron Deficiency Anemia	Phase 4
Recruiting	`NCT04405700` - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting	`NCT06258902` - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed	`NCT05487196` - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia	Phase 2
Completed	`NCT03750968` - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects	Phase 2
Enrolling by invitation	`NCT06127277` - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care	N/A
Completed	`NCT05897697` - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting	`NCT05899101` - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed	`NCT05502510` - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed	`NCT04296396` - Opioid Prescription After Cesarean Trial	Phase 3
Not yet recruiting	`NCT06069856` - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial	Phase 3
Not yet recruiting	`NCT06069869` - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial	Phase 3
Not yet recruiting	`NCT06079918` - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania	Phase 3
Not yet recruiting	`NCT06163651` - Evaluating a One-Year Version of the Parent-Child Assistance Program	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

PROphylactic Manual RotatIon in the Second stagE of Labor — PROMISE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms