Labor ComplicationPROMISENCT05175040

PROphylactic Manual RotatIon in the Second stagE of Labor

A study testing Prophylactic manual rotation in people with Labor Complication and Pregnancy Related, run by Northwestern University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Labor Complication, Pregnancy Related
What is being tested?: Prophylactic manual rotation
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: 4 Mar 2022to 15 Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Pregnant
Age 18 years or greater
English-speaking
Nulliparous
Singleton gestation
Planning a vaginal birth

Show all 12Show fewer

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

Who cannot join

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
Lack of other inclusion criteria as described above

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern Memorial Hospital
Chicago, Illinois, 60657

Other trials in United States

About this study

Official title: PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE): a Randomized Controlled Trial

Read the detailed 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.

Conditions: Labor Complication, Pregnancy Related
Being tested: Prophylactic manual rotation, Sham rotation
Medical subject headings: Obstetric Labor Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prophylactic manual rotationProcedure or surgery
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 rotationProcedure or surgery
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.

Study groups in NCT05175040
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Sham rotation

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From randomization until delivery, up to 5 hours

Secondary outcomes (18)

Number of participants in each group who undergo operative vaginal delivery
Number of participants in each group who undergo an instrumental vaginal delivery with vacuum or forceps
Measured: From randomization until delivery, up to 5 hours
Number of participants in each group who undergo cesarean delivery
Number of participants in each group who undergo a cesarean section
Measured: From randomization until delivery, up to 5 hours
Number of minutes in the second stage of labor in each group
Number of minutes participants in each group spend in the second stage of labor
Measured: From randomization until delivery, up to 300 minutes
Number of participants in each group with composite maternal morbidity
Number of participants in each group with a composite of the following individual adverse maternal outcomes: obstetric anal sphincter injury (i.e. 3rd or 4th degree perineal lacerations), postpartum hemorrhage (i.e. estimated blood loss as defined by >1000ml), blood product transfusion, intrapartum chorioamnionitis diagnosed in the second stage of labor, or postpartum endometritis
Measured: 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
Number of participants in each group who are diagnosed with intrapartum chorioamnionitis during the second stage of labor as defined by fever greater than 100.4 Fahrenheit in the intrapartum period and at least one additional clinical factor (fundal tenderness, maternal tachycardia, fetal tachycardia, or purulent discharge) with initiation of a therapeutic antibiotic regimen in the second stage of labor
Measured: From randomization until delivery, up to 5 hours
Number of participants in each group with postpartum endometritis
Number of participants in each group who experience postpartum endometritis as defined by fever greater than 100.4 Fahrenheit and one additional clinical factor (fundal tenderness or purulent lochia) in the postpartum period with the initiation of a therapeutic antibiotic regimen in the postpartum period
Measured: From delivery until hospital discharge, an expected average of 3 days
Number of participants in each group with postpartum hemorrhage
Number of participants in each group with postpartum hemorrhage (i.e. estimated blood loss as defined by >1000ml)
Measured: From randomization until hospital discharge, an expected average of 3 days
Number of participants in each group who require blood product transfusion
Number of participants in each group who require blood product transfusion
Measured: From randomization until hospital discharge, an expected average of 3 days
Number of participants in each group who experience obstetric anal sphincter injury (i.e. a composite of 3rd or 4th degree perineal lacerations)
Number of participants in each group with 3rd or 4th degree perineal lacerations as a composite outcome
Measured: From randomization until delivery, up to 5 hours
Number of participants in each group with composite severe neonatal morbidity
Number of participants in each group with neonates with the composite of the following individual adverse neonatal outcomes: 5-minute Apgar score <5, arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L, shoulder dystocia, hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage, neonatal intensive care unit (NICU) admission, or neonatal sepsis
Measured: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group who experience neonatal death
Number of participants in each group with neonates who experience neonatal death after delivery prior to hospital discharge
Measured: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group affected by neonatal intensive care unit (NICU) admission
Number of participants in each group with a neonate that requires neonatal intensive care unit (NICU) admission following delivery
Measured: From delivery until hospital discharge, up to 28 days of life
Number of days a participant in each group has a neonate requiring neonatal intensive care unit (NICU) admission
Number of days a participant in each group has a neonate that is admitted to the neonatal intensive care unit (NICU) following delivery
Measured: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group with a neonate with neonatal 5-minute Apgar score <5
Number of participants in each group with a neonate that has an Apgar score less than 5 at 5 minutes of life
Measured: From delivery up to 5 minutes of life
Number of participants in each group with a neonate with neonatal umbilical arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L
Number of participants in each group with a neonate that has an umbilical arterial cord pH less than or equal to 7.00 or base excess less than or equal to -12 milliequivalents/L as a composite outcome
Measured: At time of delivery
Number of participants in each group who experiences intrapartum shoulder dystocia
Number of participants in each group that experiences a shoulder dystocia at delivery
Measured: From randomization until delivery, up to 5 hours
Number of participants in each group with a neonate with neonatal hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage
Number of participants in each group with a neonate that experiences development of hypoxic-ischemic encephalopathy requiring hypothermic therapy or development of subgaleal or intracranial hemorrhage as a result of birth trauma or other delivery event
Measured: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group with a neonate with neonatal sepsis
Number of participants in each group with a neonate that experiences neonatal sepsis as defined by pathogenic bacterial infection confirmed in blood or cerebrospinal fluid culture
Measured: From delivery until hospital discharge, up to 28 days of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 202215 Dec 2023

First posted3 Jan 2022
Study start4 Mar 2022
Primary completion15 Dec 2023
Study completion15 Dec 2023

Why it stopped: Logistical challenges impeding enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for Labor ComplicationStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05175040
Sponsor's protocol ID: 00215006
Acronym: PROMISE
Status last verified: Mar 2024
First submitted: 8 Nov 2021
Last updated: 26 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 24565430
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.
PubMed 31976544
Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.
PubMed 32217976
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.
PubMed 27333357
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.
PubMed 15802403
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.
PubMed 15863533
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.
PubMed 11755548
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.
PubMed 12738150
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.
PubMed 7794300
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.
PubMed 17906022
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.
PubMed 23346873
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.
PubMed 15902181
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.
PubMed 16098883
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.
PubMed 16966125
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.
PubMed 16582120

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Labor Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE): a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05175040
Acronym / sponsor ID: PROMISE / 00215006
Conditions: Labor Complication, Pregnancy Related
Study type: Interventional
Recruitment status: TerminatedReason stopped: Logistical challenges impeding enrollment
Enrolment: 42 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 4 Mar 2022 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 3 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Prophylactic manual rotation	Experimental	Procedure: Prophylactic manual rotationProphylactic 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.
Sham rotation	Sham comparator	Procedure: Sham rotationSham 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Pregnant
Age 18 years or greater
English-speaking
Nulliparous
Singleton gestation

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prophylactic manual rotationProphylactic 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.	Procedure or surgery	Prophylactic manual rotation
Sham rotationSham 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.	Procedure or surgery	Sham rotation

Primary outcome

Number of participants in each group who undergo operative delivery
Time frame: From randomization until delivery, up to 5 hours
Number of participants in each group who undergo a cesarean section or an instrumental delivery (vacuum or forceps) as a composite outcome

18 secondary outcomes

Number of participants in each group who undergo operative vaginal delivery
Time frame: From randomization until delivery, up to 5 hours
Number of participants in each group who undergo cesarean delivery
Time frame: From randomization until delivery, up to 5 hours
Number of minutes in the second stage of labor in each group
Time frame: From randomization until delivery, up to 300 minutes
Number of participants in each group with composite maternal morbidity
Time frame: 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
Time frame: From randomization until delivery, up to 5 hours
Number of participants in each group with postpartum endometritis
Time frame: From delivery until hospital discharge, an expected average of 3 days
Number of participants in each group with postpartum hemorrhage
Time frame: From randomization until hospital discharge, an expected average of 3 days
Number of participants in each group who require blood product transfusion
Time frame: From randomization until hospital discharge, an expected average of 3 days
Number of participants in each group who experience obstetric anal sphincter injury (i.e. a composite of 3rd or 4th degree perineal lacerations)
Time frame: From randomization until delivery, up to 5 hours
Number of participants in each group with composite severe neonatal morbidity
Time frame: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group who experience neonatal death
Time frame: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group affected by neonatal intensive care unit (NICU) admission
Time frame: From delivery until hospital discharge, up to 28 days of life
Number of days a participant in each group has a neonate requiring neonatal intensive care unit (NICU) admission
Time frame: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group with a neonate with neonatal 5-minute Apgar score <5
Time frame: From delivery up to 5 minutes of life
Number of participants in each group with a neonate with neonatal umbilical arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L
Time frame: At time of delivery
Number of participants in each group who experiences intrapartum shoulder dystocia
Time frame: From randomization until delivery, up to 5 hours
Number of participants in each group with a neonate with neonatal hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage
Time frame: From delivery until hospital discharge, up to 28 days of life
Number of participants in each group with a neonate with neonatal sepsis
Time frame: From delivery until hospital discharge, up to 28 days of life

Results and safety

The study was stopped early (reason given: Logistical challenges impeding enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Background: PubMed 24565430American 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.
Background: PubMed 31976544Morton 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.
Background: PubMed 32217976Operative Vaginal Birth: ACOG Practice Bulletin, Number 219. Obstet Gynecol. 2020 Apr;135(4):e149-e159. doi: 10.1097/AOG.0000000000003764.
Background: PubMed 27333357American 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.
Background: PubMed 15802403Senecal 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.
Background: PubMed 15863533Lieberman 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.
Background: PubMed 11755548Fitzpatrick 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.
Background: PubMed 12738150Ponkey 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.
Background: PubMed 7794300Macara 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.
Background: PubMed 17906022Le 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.
Background: PubMed 23346873Carseldine 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.
Background: PubMed 15902181Benavides 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephanie Fisher, MD MPH study director

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic manual rotation in people with Labor Complication and Pregnancy Related, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Logistical challenges impeding enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants in each group who undergo operative delivery (time frame: From randomization until delivery, up to 5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05175040, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.