NCT07411352

Brief Summary

This randomized clinical trial aims to compare the effect of the left lateral decubitus position versus the supine position on the duration of the active phase of labor in nulliparous women. A total of 188 participants will be randomly assigned to one of two groups. The intervention group will be placed in the left lateral decubitus position, while the control group will remain in the supine position. Both positions will be maintained for 30-minute intervals with 5-minute rest periods, continuing until delivery. The primary outcome is the duration of the active phase of labor. Secondary outcomes include rates of cesarean section, use of oxytocin and analgesics, and maternal and neonatal complications.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress43%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

February 4, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 4, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

Maternal PositionLeft Lateral PositionActive Phase of LaborRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Duration of the active phase of labor.

    The primary objective is to measure and compare the time taken to progress from the active phase to delivery between the two positioning groups.

    Time (in minutes) from the diagnosis of the active phase of labor (cervical dilation ≥6 cm) to delivery of the newborn. Within the first 24 hours after diagnosis of active phase.

Secondary Outcomes (4)

  • Incidence of Cesarean Delivery

    From randomization until delivery (anticipated within 48 hours per participant).

  • Use of Oxytocin for labor augmentation/conduction.

    From randomization until delivery.

  • Incidence of maternal complications (e.g., perineal tears, hemorrhage, hypotension).

    From randomization until hospital discharge (approximately 24-48 hours postpartum).

  • Neonatal status as measured by Apgar score.

    At 1 minute and 5 minutes after birth.

Study Arms (2)

Left Lateral Decubitus Position

EXPERIMENTAL

Participants will be placed in the left lateral decubitus position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.

Other: Left Lateral Decubitus Group

Supine Position Group

ACTIVE COMPARATOR

Participants will remain in the supine position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.

Other: Supine Position Group

Interventions

Participants will be placed in the left lateral decubitus position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.

Left Lateral Decubitus Position

Participants will remain in the supine position for periods of 30 minutes, interspersed with 5-minute rest periods. This cycle will continue throughout the active phase of labor until delivery.

Supine Position Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on sex, not gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed and dated informed consent form.
  • Nulliparous woman.
  • Singleton pregnancy at ≥37 weeks of gestation.
  • Intact amniotic membranes.
  • Cephalic presentation.
  • In the active phase of labor (cervical dilation ≥6 cm).
  • Age ≥18 years.
  • No contraindication for vaginal delivery.
  • Possession of a mobile phone (for potential follow-up contact).

You may not qualify if:

  • Previous uterine surgery.
  • Maternal condition preventing vaginal delivery.
  • Fetal anomaly.
  • Premature rupture of membranes.
  • Multiple pregnancy.
  • Fetal demise.
  • Uterine myomas.
  • Maternal comorbidities (e.g., chronic hypertension, diabetes mellitus type -1/2/gestational, hypothyroidism).
  • Anemia.
  • Age \<18 years.
  • Preterm gestation (\<37 weeks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

RECRUITING

Related Publications (1)

  • Gupta JK, Hofmeyr GJ, Shehmar M. Position in the second stage of labour for women without epidural anaesthesia. Cochrane Database Syst Rev. 2012 May 16;(5):CD002006. doi: 10.1002/14651858.CD002006.pub3.

    PMID: 22592681BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ricardo A. Gutierrez Ramirez, MD, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The groups will be labeled "AGroup" and "B Group" during data collection and tabulation. The statistician performing the analysis will be blinded to which group corresponds to which intervention until the analysis is complete.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 allocation ratio. It employs a superiority framework to test the hypothesis that the left lateral decubitus position is superior to the standard supine position for reducing the duration of the active phase of labor. The design is single-blind, where the outcome assessors and data analysts are masked to group assignment. Due to the physical nature of the intervention (maternal positioning), participants and the healthcare providers implementing the position cannot be blinded. This is a single-center efficacy trial conducted in a real-world hospital labor and delivery setting.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 13, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations