PROphylactic Manual RotatIon in the Second stagE of Labor
NCT ID: NCT05175040
Last Updated: 2024-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
42 participants
INTERVENTIONAL
2022-03-04
2023-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Prophylactic manual rotation
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.
Prophylactic manual rotation
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.
Sham rotation
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.
Sham rotation
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.
Interventions
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Prophylactic manual rotation
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.
Sham rotation
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Stephanie Fisher
Assistant Professor of Obstetrics and Gynecology (Maternal Fetal Medicine)
Principal Investigators
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Stephanie Fisher, MD MPH
Role: STUDY_DIRECTOR
Northwestern University
Locations
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Northwestern Memorial Hospital
Chicago, Illinois, United States
Countries
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References
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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.
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.
Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.
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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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00215006
Identifier Type: -
Identifier Source: org_study_id
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