Maternal Positioning to Correct Fetal Occiput Posterior

August 15, 2022 updated by: Northwell Health

Maternal Positioning to Correct Fetal Occiput Posterior in the First Stage of Labor

In evaluating a patient's ability to have a normal vaginal delivery, a practitioner must consider three factors. Commonly referred to as the three P's, these include Power (contractions), Passage (pelvis and soft tissue) and passenger (baby). Power can be controlled through induction and augmentation agents. Passage is determined by the women's body habitus. Passenger includes the baby's estimated fetal weight (EFW) and position. Throughout the history of obstetrics, the baby's position has been a factor that has acted as a strong predictor of a woman's ability to deliver vaginally. Several researchers have looked into the percentage of babies born in the Occiput Anterior (fetus facing down) vs. Occiput Posterior (fetus facing up aka "sunny side up") position. Studies have shown that the majority of babies are born in OA position and that the finding of an OA positioned baby is associated with a greater likelihood of a successful vaginal delivery. OP position is associated with higher risk of 3rd and 4th degree perineal lacerations, operative delivery (vacuum/forceps) and cesarean section. Therefore OP position poses a higher risk of morbidity to the patient and fetus. Multiple studies exist in the obstetrics and midwifery literature regarding maternal positioning to correct fetal malposition. Many of these studies have shown no significance and those that do have generated conflicting results and are consistently lacking in power. The aim of this prospective study is to determine if maternal positioning to either the side of fetal movement (contralateral/opposite to the fetal spine) or opposite of the side of fetal movement (ipsilateral to the fetal spine) during the first stage of labor is associated with correction of fetal OP to OA position. Upon admission to labor and delivery, following an initial ultrasound to confirm fetal OP position, women in this study will be randomly assigned to one of three groups; one control (Group A), and two experimental (Groups B and C) groups. Those assigned to Group A will be allowed to remain in any position they chose during their labor and delivery course. Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement. Group C, will be placed in the same position but opposite that of which fetal kicks are felt. Subjects in the experimental group will be asked to remain in these positions throughout the majority of their labor and delivery course, up until the second stage of labor (10 cm dilated). They will be allowed to change positions for up to 10 min per hour for maternal comfort and any fetal resuscitation efforts. Anything longer than this will be considered a deviation from the protocol and will be documented as such, but all necessary intervention for fetal well-being will be allowed including changes in maternal position for longer than 10 minutes. Once a cervical dilation of 10cm is achieved all study interventions will be discontinued. Peanut balls and manual rotational maneuvers will not be allowed as they are considered confounding factors which may individually affect fetal position. Data will be collected from the hospital record. This data will include: maternal age, BMI, race, maternal medical complications, delivery type, laceration, fetal position at delivery, dilation on admission and weight of the baby.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
465

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Emma Brenner, MD

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who are >/=18yo
  • able to consent
  • >/=37 weeks gestation (full term) with a viable singleton intrauterine pregnancy noted to be cephalic presentation in the OP position at the time of admission as noted on bedside ultrasound
  • All patients must be <10cm, with a score of 3 or less out of 10 on a numeric pain rating scale
  • admitted to LIJ or NSUH for either spontaneous labor or labor induction.

Exclusion Criteria:

  • All women younger than 18yo
  • unable to consent
  • admitted in the second stage of labor (>10cm) or beyond, with nonviable pregnancies (i.e. IUFD), score of 4 or more on a numeric pain rating scale, or desiring cesarean section will be excluded.
  • all women with pregnancies noted to have IUGR, fetal anomalies, malpresentation (i.e. breech), multiple gestations or fetuses not in the OP position at time of admission will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: A
Experimental: B
Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement.
Behavioral: Positioning
Upon admission to labor and delivery, following an initial ultrasound to confirm fetal OP position, women in this study will be randomly assigned to one of three groups; one control (Group A), and two experimental (Groups B and C) groups. Those assigned to Group A will be allowed to remain in any position they chose during their labor and delivery course. Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement. Group C, will be placed in the same position but opposite that of which fetal kicks are felt.
Experimental: C
Group C, will be placed in the same position but opposite that of which fetal kicks are felt.
Behavioral: Positioning
Upon admission to labor and delivery, following an initial ultrasound to confirm fetal OP position, women in this study will be randomly assigned to one of three groups; one control (Group A), and two experimental (Groups B and C) groups. Those assigned to Group A will be allowed to remain in any position they chose during their labor and delivery course. Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement. Group C, will be placed in the same position but opposite that of which fetal kicks are felt.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fetal Position at time of delivery
Time Frame: From time of admission to delivery
Rate of OA position in each arm at time of delivery
From time of admission to delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: From time of admission to delivery
Vaginal delivery rates in each arm
From time of admission to delivery
Laceration Type
Time Frame: From time of admission to delivery
Incidence of 3rd and 4th degree lacerations in each arm
From time of admission to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwell Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Valerie Schulz, MD, Northwell Health
  • Principal Investigator: Sarah Pachtman, MD, Northwell Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 21-0519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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