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Obstetric ComplicationNCT05307393

Maternal Positioning to Correct Fetal Occiput Posterior

A study testing Positioning in people with Obstetric Complication, run by Northwell Health at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Obstetric Complication
What is being tested?
Positioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
465 participants
Where
1 siteUnited States
Study dates
1 Jan 2024to 1 Jan 2025
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Emma Brenner, MD contact

7184707660

ebrenner@northwell.edu

Emma Brenner, MD contact

United States1 site
  • Long Island Jewish medical center

    New Hyde Park, New York, 11040

Other trials in United States

About this study

Official title: 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.

Being tested
Positioning

What participants receive

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

  • PositioningBehavioural

    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.

Study groups in NCT05307393
Study groupRoleWhat they receive
ANo interventionNot described
BExperimentalGroup B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement.
Receives: Behavioral: Positioning
CExperimentalGroup C, will be placed in the same position but opposite that of which fetal kicks are felt.
Receives: Behavioral: Positioning

What is being measured

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

  1. Fetal Position at time of delivery

    Rate of OA position in each arm at time of delivery

    Measured: From time of admission to delivery

Secondary outcomes (2)
  1. Mode of delivery

    Vaginal delivery rates in each arm

    Measured: From time of admission to delivery

  2. Laceration Type

    Incidence of 3rd and 4th degree lacerations in each arm

    Measured: From time of admission to delivery

Timeline

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

  1. First posted1 Apr 2022
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
465 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05307393
Sponsor's protocol ID
21-0519
Status last verified
Mar 2023
First submitted
24 Mar 2022
Last updated
8 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Positioning in people with Obstetric Complication, run by Northwell Health 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2023. 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. 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?

Results are not available in the source record.

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

Contact Emma Brenner, MD (7184707660, ebrenner@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fetal Position at time of delivery (time frame: From time of admission to delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 8 Mar 2023.

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