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PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE)

Primary Purpose

Labor Complication, Pregnancy Related

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prophylactic manual rotation
Sham rotation
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Complication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Northwestern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Prophylactic manual rotation

Sham rotation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Number of participants in each group who undergo cesarean delivery
Number of participants in each group who undergo a cesarean section
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
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
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
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
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)
Number of participants in each group who require blood product transfusion
Number of participants in each group who require blood product transfusion
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
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
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
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
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
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
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
Number of participants in each group who experiences intrapartum shoulder dystocia
Number of participants in each group that experiences a shoulder dystocia at delivery
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
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

Full Information

First Posted
November 8, 2021
Last Updated
March 29, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05175040
Brief Title
PROphylactic Manual RotatIon in the Second stagE of Labor
Acronym
PROMISE
Official Title
PROphylactic Manual RotatIon in the Second stagE of Labor (PROMISE): a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication, Pregnancy Related

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
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.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic manual rotation
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham rotation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prophylactic manual rotation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham rotation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants in each group who undergo operative delivery
Description
Number of participants in each group who undergo a cesarean section or an instrumental delivery (vacuum or forceps) as a composite outcome
Time Frame
From randomization until delivery, up to 5 hours
Secondary Outcome Measure Information:
Title
Number of participants in each group who undergo operative vaginal delivery
Description
Number of participants in each group who undergo an instrumental vaginal delivery with vacuum or forceps
Time Frame
From randomization until delivery, up to 5 hours
Title
Number of participants in each group who undergo cesarean delivery
Description
Number of participants in each group who undergo a cesarean section
Time Frame
From randomization until delivery, up to 5 hours
Title
Number of minutes in the second stage of labor in each group
Description
Number of minutes participants in each group spend in the second stage of labor
Time Frame
From randomization until delivery, up to 300 minutes
Title
Number of participants in each group with composite maternal morbidity
Description
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
Time Frame
From randomization until hospital discharge, an expected average of 3 days
Title
Number of participants in each group with maternal intrapartum chorioamnionitis diagnosed in the second stage of labor
Description
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
Time Frame
From randomization until delivery, up to 5 hours
Title
Number of participants in each group with postpartum endometritis
Description
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
Time Frame
From delivery until hospital discharge, an expected average of 3 days
Title
Number of participants in each group with postpartum hemorrhage
Description
Number of participants in each group with postpartum hemorrhage (i.e. estimated blood loss as defined by >1000ml)
Time Frame
From randomization until hospital discharge, an expected average of 3 days
Title
Number of participants in each group who require blood product transfusion
Description
Number of participants in each group who require blood product transfusion
Time Frame
From randomization until hospital discharge, an expected average of 3 days
Title
Number of participants in each group who experience obstetric anal sphincter injury (i.e. a composite of 3rd or 4th degree perineal lacerations)
Description
Number of participants in each group with 3rd or 4th degree perineal lacerations as a composite outcome
Time Frame
From randomization until delivery, up to 5 hours
Title
Number of participants in each group with composite severe neonatal morbidity
Description
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
Time Frame
From delivery until hospital discharge, up to 28 days of life
Title
Number of participants in each group who experience neonatal death
Description
Number of participants in each group with neonates who experience neonatal death after delivery prior to hospital discharge
Time Frame
From delivery until hospital discharge, up to 28 days of life
Title
Number of participants in each group affected by neonatal intensive care unit (NICU) admission
Description
Number of participants in each group with a neonate that requires neonatal intensive care unit (NICU) admission following delivery
Time Frame
From delivery until hospital discharge, up to 28 days of life
Title
Number of days a participant in each group has a neonate requiring neonatal intensive care unit (NICU) admission
Description
Number of days a participant in each group has a neonate that is admitted to the neonatal intensive care unit (NICU) following delivery
Time Frame
From delivery until hospital discharge, up to 28 days of life
Title
Number of participants in each group with a neonate with neonatal 5-minute Apgar score <5
Description
Number of participants in each group with a neonate that has an Apgar score less than 5 at 5 minutes of life
Time Frame
From delivery up to 5 minutes of life
Title
Number of participants in each group with a neonate with neonatal umbilical arterial cord pH ≤7.00 or base excess ≤-12 milliequivalents/L
Description
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
Time Frame
At time of delivery
Title
Number of participants in each group who experiences intrapartum shoulder dystocia
Description
Number of participants in each group that experiences a shoulder dystocia at delivery
Time Frame
From randomization until delivery, up to 5 hours
Title
Number of participants in each group with a neonate with neonatal hypoxic-ischemic encephalopathy requiring hypothermic therapy or neonatal subgaleal or intracranial hemorrhage
Description
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
Time Frame
From delivery until hospital discharge, up to 28 days of life
Title
Number of participants in each group with a neonate with neonatal sepsis
Description
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
Time Frame
From delivery until hospital discharge, up to 28 days of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Fisher, MD MPH
Phone
312-681-5674
Email
stephanie.fisher@nm.org
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Miller, MD MPH
Phone
312-695-7542
Email
emiller@nm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Fisher, MD MPH
Organizational Affiliation
Northwestern University
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Fisher, MD
Phone
312-472-4685
Email
stephanie.fisher@nm.org

12. IPD Sharing Statement

Plan to Share IPD
No
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PROphylactic Manual RotatIon in the Second stagE of Labor

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