PROphylactic Manual RotatIon in the Second stagE of Labor

NCT05175040 | Terminated DMC

• 1 other identifier: 00215006
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Complication; Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• Number of participants in each group who undergo operative delivery

  Number of participants in each group who undergo a cesarean section or an instrumental delivery (vacuum or forceps) as a composite outcome

  From randomization until delivery, up to 5 hours

Secondary Outcomes (18)

• Number of participants in each group who undergo operative vaginal delivery

  From randomization until delivery, up to 5 hours

• Number of participants in each group who undergo cesarean delivery

  From randomization until delivery, up to 5 hours

• Number of minutes in the second stage of labor in each group

  From randomization until delivery, up to 300 minutes

• Number of participants in each group with composite maternal morbidity

  From randomization until hospital discharge, an expected average of 3 days

• Number of participants in each group with maternal intrapartum chorioamnionitis diagnosed in the second stage of labor

  From randomization until delivery, up to 5 hours

Study Arms (2)

Prophylactic manual rotation

EXPERIMENTAL

Prophylactic manual rotation involves a vaginal examination performed with an obstetric provider's hands to turn the baby from a position in which the baby's face is looking up in the direction of the ceiling (occiput posterior) or to the side (occiput transverse) to a position in which the baby's face is looking down in the direction of the mother's spine (occiput anterior). Prophylactic manual rotation will occur at the initiation of pushing once the individual achieves complete cervical dilation.

Procedure: Prophylactic manual rotation

Sham rotation

SHAM COMPARATOR

Sham rotation involves a vaginal exam that obstetric providers commonly do with their hands to assess cervical dilation and fetal position during routine labor, and will occur at the initiation of pushing once the individual achieves complete cervical dilation.

Procedure: Sham rotation

Interventions

Prophylactic manual rotation PROCEDURE

Prophylactic manual rotation, performed in the experimental arm, involves a vaginal examination performed with an obstetric provider's hands to turn the baby from a position in which the baby's face is looking up in the direction of the ceiling (occiput posterior) or to the side (occiput transverse) to a position in which the baby's face is looking down in the direction of the mother's spine (occiput anterior). Prophylactic manual rotation will occur at the initiation of pushing once the individual achieves complete cervical dilation, performed by a trained study investigator (M.D. or midwife) to maintain blinding of the patient's primary obstetrician.

Prophylactic manual rotation

Sham rotation PROCEDURE

Sham rotation, performed in the comparator arm, involves a vaginal exam that obstetric providers commonly do with their hands to assess cervical dilation and fetal position during routine labor, and will occur at the initiation of pushing once the individual achieves complete cervical dilation. Duration of the vaginal exam for sham rotation will be consistent with that used for prophylactic manual rotation and will be performed by a trained study investigator (M.D. or midwife) to maintain blinding of the patient's primary obstetrician.

Sham rotation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant
• Age 18 years or greater
• English-speaking
• Nulliparous
• Singleton gestation
• Planning a vaginal birth
• Have neuraxial anesthesia
• Term gestation (≥37 weeks' gestation)
• Ruptured membranes
• Complete cervical dilation
• Cephalic presenting fetus
• Fetus presenting with occiput posterior or occiput transverse position confirmed by ultrasound

You may not qualify if:

• Pregnancies with intrauterine fetal demise
• Pregnancies affected by major fetal anomaly
• Maternal or fetal contraindication to vaginal delivery, including operative vaginal delivery
• Fetal malpresentation, including brow or face presentation
• Category III fetal heart rate tracing at time of randomization
• Duration of pushing already exceeding 15 minutes in the second stage of labor

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60657, United States

Location

Related Publications (25)

• American College of Obstetricians and Gynecologists (College); Society for Maternal-Fetal Medicine; Caughey AB, Cahill AG, Guise JM, Rouse DJ. Safe prevention of the primary cesarean delivery. Am J Obstet Gynecol. 2014 Mar;210(3):179-93. doi: 10.1016/j.ajog.2014.01.026.

  PMID: 24565430 BACKGROUND

• Morton R, Burton AE, Kumar P, Hyett JA, Phipps H, McGeechan K, de Vries BS. Cesarean delivery: Trend in indications over three decades within a major city hospital network. Acta Obstet Gynecol Scand. 2020 Jul;99(7):909-916. doi: 10.1111/aogs.13816. Epub 2020 Feb 12.

  PMID: 31976544 BACKGROUND

• Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.

  PMID: 32217976 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 165: Prevention and Management of Obstetric Lacerations at Vaginal Delivery. Obstet Gynecol. 2016 Jul;128(1):e1-e15. doi: 10.1097/AOG.0000000000001523.

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• Senecal J, Xiong X, Fraser WD; Pushing Early Or Pushing Late with Epidural study group. Effect of fetal position on second-stage duration and labor outcome. Obstet Gynecol. 2005 Apr;105(4):763-72. doi: 10.1097/01.AOG.0000154889.47063.84.

  PMID: 15802403 BACKGROUND

• Lieberman E, Davidson K, Lee-Parritz A, Shearer E. Changes in fetal position during labor and their association with epidural analgesia. Obstet Gynecol. 2005 May;105(5 Pt 1):974-82. doi: 10.1097/01.AOG.0000158861.43593.49.

  PMID: 15863533 BACKGROUND

• Fitzpatrick M, McQuillan K, O'Herlihy C. Influence of persistent occiput posterior position on delivery outcome. Obstet Gynecol. 2001 Dec;98(6):1027-31. doi: 10.1016/s0029-7844(01)01600-3.

  PMID: 11755548 BACKGROUND

• Ponkey SE, Cohen AP, Heffner LJ, Lieberman E. Persistent fetal occiput posterior position: obstetric outcomes. Obstet Gynecol. 2003 May;101(5 Pt 1):915-20. doi: 10.1016/s0029-7844(03)00068-1.

  PMID: 12738150 BACKGROUND

• Macara LM, Murphy KW. The contribution of dystocia to the cesarean section rate. Am J Obstet Gynecol. 1994 Jul;171(1):71-7. doi: 10.1016/s0002-9378(94)70080-x.

  PMID: 7794300 BACKGROUND

• Le Ray C, Serres P, Schmitz T, Cabrol D, Goffinet F. Manual rotation in occiput posterior or transverse positions: risk factors and consequences on the cesarean delivery rate. Obstet Gynecol. 2007 Oct;110(4):873-9. doi: 10.1097/01.AOG.0000281666.04924.be.

  PMID: 17906022 BACKGROUND

• Carseldine WJ, Phipps H, Zawada SF, Campbell NT, Ludlow JP, Krishnan SY, De Vries BS. Does occiput posterior position in the second stage of labour increase the operative delivery rate? Aust N Z J Obstet Gynaecol. 2013 Jun;53(3):265-70. doi: 10.1111/ajo.12041. Epub 2013 Jan 24.

  PMID: 23346873 BACKGROUND

• Benavides L, Wu JM, Hundley AF, Ivester TS, Visco AG. The impact of occiput posterior fetal head position on the risk of anal sphincter injury in forceps-assisted vaginal deliveries. Am J Obstet Gynecol. 2005 May;192(5):1702-6. doi: 10.1016/j.ajog.2004.11.047.

  PMID: 15902181 BACKGROUND

• Wu JM, Williams KS, Hundley AF, Connolly A, Visco AG. Occiput posterior fetal head position increases the risk of anal sphincter injury in vacuum-assisted deliveries. Am J Obstet Gynecol. 2005 Aug;193(2):525-8; discussion 528-9. doi: 10.1016/j.ajog.2005.03.059.

  PMID: 16098883 BACKGROUND

• Cheng YW, Shaffer BL, Caughey AB. Associated factors and outcomes of persistent occiput posterior position: A retrospective cohort study from 1976 to 2001. J Matern Fetal Neonatal Med. 2006 Sep;19(9):563-8. doi: 10.1080/14767050600682487.

  PMID: 16966125 BACKGROUND

• Cheng YW, Shaffer BL, Caughey AB. The association between persistent occiput posterior position and neonatal outcomes. Obstet Gynecol. 2006 Apr;107(4):837-44. doi: 10.1097/01.AOG.0000206217.07883.a2.

  PMID: 16582120 BACKGROUND

• Le Ray C, Deneux-Tharaux C, Khireddine I, Dreyfus M, Vardon D, Goffinet F. Manual rotation to decrease operative delivery in posterior or transverse positions. Obstet Gynecol. 2013 Sep;122(3):634-40. doi: 10.1097/AOG.0b013e3182a10e43.

  PMID: 23921875 BACKGROUND

• Shaffer BL, Cheng YW, Vargas JE, Caughey AB. Manual rotation to reduce caesarean delivery in persistent occiput posterior or transverse position. J Matern Fetal Neonatal Med. 2011 Jan;24(1):65-72. doi: 10.3109/14767051003710276. Epub 2010 Mar 30.

  PMID: 20350240 BACKGROUND

• Reichman O, Gdansky E, Latinsky B, Labi S, Samueloff A. Digital rotation from occipito-posterior to occipito-anterior decreases the need for cesarean section. Eur J Obstet Gynecol Reprod Biol. 2008 Jan;136(1):25-8. doi: 10.1016/j.ejogrb.2006.12.025. Epub 2007 Mar 21.

  PMID: 17368909 BACKGROUND

• Graham K, Phipps H, Hyett JA, Ludlow JP, Mackie A, Marren A, De Vries B. Persistent occiput posterior: OUTcomes following digital rotation: a pilot randomised controlled trial. Aust N Z J Obstet Gynaecol. 2014 Jun;54(3):268-74. doi: 10.1111/ajo.12192. Epub 2014 Mar 16.

  PMID: 24627988 BACKGROUND

• Phipps H, Hyett JA, Kuah S, Pardey J, Matthews G, Ludlow J, Narayan R, Santiagu S, Earl R, Wilkinson C, Bisits A, Carseldine W, Tooher J, McGeechan K, de Vries B. Persistent occiput posterior position outcomes following manual rotation: a randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Mar;3(2):100306. doi: 10.1016/j.ajogmf.2021.100306. Epub 2021 Jan 6.

  PMID: 33418103 BACKGROUND

• Broberg JC, Caughey AB. A randomized controlled trial of prophylactic early manual rotation of the occiput posterior fetus at the beginning of the second stage vs expectant management. Am J Obstet Gynecol MFM. 2021 Mar;3(2):100327. doi: 10.1016/j.ajogmf.2021.100327. Epub 2021 Feb 2.

  PMID: 33545441 BACKGROUND

• Blanc J, Castel P, Mauviel F, Baumstarck K, Bretelle F, D'Ercole C, Haumonte JB. Prophylactic manual rotation of occiput posterior and transverse positions to decrease operative delivery: the PROPOP randomized clinical trial. Am J Obstet Gynecol. 2021 Oct;225(4):444.e1-444.e8. doi: 10.1016/j.ajog.2021.05.020. Epub 2021 May 24.

  PMID: 34033811 BACKGROUND

• Le Ray C, Goffinet F. [Manual rotation of occiput posterior presentation]. Gynecol Obstet Fertil. 2011 Oct;39(10):575-8. doi: 10.1016/j.gyobfe.2011.08.038. Epub 2011 Sep 15. French.

  PMID: 21924659 BACKGROUND

• Verhaeghe C, Parot-Schinkel E, Bouet PE, Madzou S, Biquard F, Gillard P, Descamps P, Legendre G. The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS). Trials. 2018 Feb 14;19(1):109. doi: 10.1186/s13063-018-2497-7.

  PMID: 29444695 BACKGROUND

• Verhaeghe C, Corroenne R, Spiers A, Descamps P, Gascoin G, Bouet PE, Parot-Schinkel E, Legendre G. Delivery Mode After Manual Rotation of Occiput Posterior Fetal Positions: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jun 1;137(6):999-1006. doi: 10.1097/AOG.0000000000004386.

  PMID: 33957650 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Stephanie Fisher, MD MPH

  Northwestern University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both the study participant and her primary obstetrician will be blinded to the assigned randomization arm prior to delivery, as involvement in this research study should not change their care. Clinical management will be left to the discretion of each participant's primary obstetrician managing her labor, according to standard obstetrical care, who again will not be involved in the research-related study procedures.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology (Maternal Fetal Medicine)

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: January 3, 2022
• Study Start: March 4, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)