NCT06928038

Brief Summary

This is a randomized controlled experimental study to determine the effect of maternal position on the progression of labour in deliveries in which the foetus is in the occiput posterior position. The study included 148 gravidas admitted to a private Istanbul hospital, who consented to participate. They were divided into intervention and control groups (n=72). The intervention group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. The control group received routine delivery care.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.9 years

First QC Date

March 28, 2025

Last Update Submit

April 15, 2025

Conditions

Keywords

Foetal malpositionOcciput posterior stanceDelivery positions

Outcome Measures

Primary Outcomes (2)

  • birth type of the baby

    cesarean section, spontaneously deliver

    from labor to the end of the delivery

  • Head position

    right - left occiput posterior; right - left occiput transverse; right - left occiput anterior

    From labor to the expulsion stage

Secondary Outcomes (1)

  • duration of expulsion phase

    duration of expulsion phase

Study Arms (2)

Intervention group

EXPERIMENTAL

The positioned group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position.

Behavioral: Positioned group

Control group

NO INTERVENTION

The control group was followed up in the routine delivery room, and no positioning was done.

Interventions

applied a side-lying position (20 minutes) on the occiput side and a prostrate position (15 minutes).

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gravidas aged 18 years or older
  • Between 36 and 42 weeks of gestation
  • Willing to participate in the study
  • Expected to deliver vaginally
  • Not classified as high-risk
  • No obstetric or medical complications during labor
  • Single, healthy fetus in one of the following positions: occiput posterior, left occiput posterior, right occiput posterior, left occiput transverse, or right occiput transverse (confirmed via ultrasonography)
  • Cervical dilation of at least 2-3 cm
  • Estimated fetal weight between 2500 g and 3999 g
  • No major congenital anomalies

You may not qualify if:

  • Inability to understand Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dystocia

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The study included 148 gravidas admitted to a private Istanbul hospital, who consented to participate. They were divided into intervention and control groups (n=72). The intervention group assumed a side-lying position on the occiput side for 20 minutes, a prostrate position for 15 minutes, then leaned towards the bed's head for 10 minutes (rest), followed by another 20-minute side-lying position. The control group received routine delivery care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 15, 2025

Study Start

February 1, 2015

Primary Completion

December 30, 2016

Study Completion

April 30, 2017

Last Updated

April 17, 2025

Record last verified: 2025-04