Latent Phase Membrane Stripping for Caesarean Section Reduction

NCT ID: NCT06809985

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-09-01

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.

Detailed Description

There is a need to find non-pharmacological interventions that can speed up delivery to prevent maternal complications and reduce the number of caesarean sections.

Maternal mortality remains one of the biggest health problems worldwide. Every day, around 830 women die worldwide from complications related to pregnancy or childbirth. In 2015, an estimated 303,000 women died during pregnancy and childbirth or after. Most of these deaths occur in low-income countries and most of them could have been prevented. The maternal mortality rate in Latin American and Caribbean countries, calculated by the Inter-Agency Group (MMEIG), shows a significant decrease as a regional average in recent years, from 88 per 100,000 live births in 2005 to 67 per 100,000 live births in 2015.

At the Escuela Hospital, the availability of beds and admission criteria in the intensive care unit (ICU) are not the same. The use of this marker is questionable, since it is affected by the level of complexity of the care provided to a health setting and the organization of obstetric care. We found in our study a cesarean section rate (almost 63.2%), with no significant variation by different criteria. This finding is consistent with that reported by Nelissen et al. Due to the severity of the obstetric conditions of these patients, their pregnancy usually requires urgent action. Although cesarean section is associated with high rates of maternal morbidity and mortality compared to vaginal delivery, when clinically indicated, timely termination of pregnancy can reduce the risk of maternal-fetal death.

Based on the above, this research proposes the importance of finding strategies to reduce the rate of cesarean deliveries and thus counteract the high rates of maternal morbidity and mortality. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hamilton maneuver

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.

Group Type: EXPERIMENTAL

Hamilton maneuver

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hamilton maneuver

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.

Intervention Type: PROCEDURE

Other Intervention Names

membrane decollege; membrane sweep

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

OTHER

Sponsor Role: lead

Responsible Party

Ricardo A Gutierrez Ramirez, MD, MSc, FACOG

Titular professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ricardo A. Gutierrez Ramirez, MD, MSc.

Role: STUDY_DIRECTOR

Universidad Nacional Autonoma de Honduras

Locations

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, Honduras

Countries

Honduras

References

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.

Reference Type: BACKGROUND

PMID: 32103497 (View on PubMed)

Other Identifiers

PGO-UNAH-48-6-2025

Identifier Type: -

Identifier Source: org_study_id