Latent Phase Membrane Stripping for Caesarean Section Reduction

NCT06809985 | Completed DMC

• 1 other identifier: PGO-UNAH-48-6-2025
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

In the Hospital Escuela, the availability of beds and criteria for admission to the intensive care unit ICU are not the same, the use of this marker is questionable, as it is affected by the level of complexity of care provided to a health setting and the organization of obstetric care. The cesarean section rate (almost 63.2%), is without significant variation by different criteria. The importance of finding strategies to reduce the rate of cesarean births and thus counteract the high rates of maternal morbidity and mortality is proposed. For this reason, this research is aimed at reducing the latent phase of labor through the use of the Hamilton maneuver.

Conditions

Cesarean Delivery; Cervical Ripening; Latent Phase Labour

Keywords

Cesarean Delivery; Cervical ripening; latent phase labour; hamilton maneuver

Outcome Measures

Primary Outcomes (1)

• Time from admission until active phase

  time from the intervention to reach a cervical dilatation greater than or equal to 5 cm

  Since intervention until 20 hours

Secondary Outcomes (3)

• Rate of cesarean births

  Since intervention until 7 days or maternal discharge

• Level of Maternal satisfaction

  Since intervention until 24 hours of delivery or maternal discharge

• Rate of maternal complications

  Since intervention until 14 days

Study Arms (2)

Hamilton maneuver

EXPERIMENTAL

The Hamilton maneuver is performed by inserting one or two fingers through the internal cervical os and carefully producing a circumferential rotational movement through the uterine segment in order to separate the fetal membranes from the decidua. This maneuver is recommended in order to reduce the need for formal induction.

Procedure: Hamilton maneuver

Control

NO INTERVENTION

A normal gynecological evaluation will be performed, no additional maneuvers will be performed in addition to the routine evaluation of the patient.

Interventions

Hamilton maneuver PROCEDURE

The Hamilton maneuver is performed by inserting one or two fingers through the internal cervical os and carefully producing a circumferential rotational movement through the uterine segment in order to separate the fetal membranes from the decidua. This maneuver is recommended in order to reduce the need for formal induction.

Also known as: membrane decollege, membrane sweep

Hamilton maneuver

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Submission of a signed and dated informed consent form.
• Declared willingness to comply with all study procedures and availability for the duration of the study.
• nulliparous
• woman with singleton pregnancy at 37 weeks or more
• integral membranes
• cephalic presentation
• Bishop's score less than 7
• No contraindication for vaginal delivery

You may not qualify if:

• Previous uterine surgery
• Maternal condition preventing vaginal delivery
• Fetal anomaly
• Premature rupture of membranes
• Multiple pregnancy
• Fetal orbit
• Myomas
• Maternal comorbidities such as chronic arterial hypertension, type 1, 2 and gestational diabetes, hypothyroidism, among others.
• Anemia

Sponsors & Collaborators

• Ricardo A Gutierrez Ramirez, MD, MSc, FACOG: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (1)

• Finucane EM, Murphy DJ, Biesty LM, Gyte GM, Cotter AM, Ryan EM, Boulvain M, Devane D. Membrane sweeping for induction of labour. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD000451. doi: 10.1002/14651858.CD000451.pub3.

  PMID: 32103497 BACKGROUND

Study Officials

• Ricardo A. Gutierrez Ramirez, MD, MSc.

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both the patient and the principal investigator will know the intervention, the data analyst researcher does not know the group to which the patients have been assigned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Titular professor

Model Details: Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: February 5, 2025
• Study Start: January 31, 2025
• Primary Completion: July 31, 2025
• Study Completion: September 1, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)