Left Lateral Position vs Supine Position to Reduce Active Labor Duration (DLI-SP)
Left Lateral Position Versus Supine Position in Reducing the Duration of the Active Phase of Labor: A Randomized, Single-Blind Clinical Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Ricardo A. Gutierrez Ramirez, MD, MSc
- Phone Number: +50497546940
- Email: ricardo.gutierrez@unah.edu.hn
Study Locations
-
-
Francisco Morazán Department
-
Tegucigalpa, Francisco Morazán Department, Honduras, 11101
- Recruiting
- Hospital Escuela
-
Contact:
- Ricardo A Gutierrez Ramirez, MD, MSc.
- Phone Number: 50497546940
- Email: ricardo.gutierrez@unah.edu.hn
-
Principal Investigator:
- Adriana P Mendoza Batres, MD
-
Principal Investigator:
- Kevin O Ponce Rodriguez, MD
-
Sub-Investigator:
- Juan J Galeas Reyes, MD
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Left Lateral Decubitus Position
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.
|
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.
|
|
Active Comparator: Supine Position Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of the active phase of labor.
Time Frame: 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.
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Cesarean Delivery
Time Frame: From randomization until delivery (anticipated within 48 hours per participant).
|
The proportion of participants in each group who undergo a cesarean section.
|
From randomization until delivery (anticipated within 48 hours per participant).
|
|
Use of Oxytocin for labor augmentation/conduction.
Time Frame: From randomization until delivery.
|
The proportion of participants in each group who receive oxytocin infusion.
|
From randomization until delivery.
|
|
Incidence of maternal complications (e.g., perineal tears, hemorrhage, hypotension).
Time Frame: From randomization until hospital discharge (approximately 24-48 hours postpartum).
|
Composite of adverse maternal outcomes recorded during labor and the immediate postpartum period.
|
From randomization until hospital discharge (approximately 24-48 hours postpartum).
|
|
Neonatal status as measured by Apgar score.
Time Frame: At 1 minute and 5 minutes after birth.
|
The Apgar score (0-10) will be recorded and compared between groups.
|
At 1 minute and 5 minutes after birth.
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- PGO-UNAH-49-1-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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