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CompletedNCT06809985DEMEMUpdated Dec 4, 2025

Latent Phase Membrane Stripping for Caesarean Section Reduction

An interventional study of Hamilton maneuver in Cesarean Delivery, Cervical Ripening and Latent Phase Labour, sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG. Completed at 1 site in Honduras. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Cesarean Delivery
  • Cervical Ripening
  • Latent Phase Labour

Keywords

  • Cesarean Delivery
  • Cervical ripening
  • latent phase labour
  • hamilton maneuver
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In context

Lead sponsor

Ricardo A Gutierrez Ramirez, MD, MSc, FACOG is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Submission of a signed and dated 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 for vaginal delivery

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    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.

    Procedure: Hamilton maneuver

  • No intervention
    Control

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

Interventions

  • ProcedureHamilton 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.

    Also known as: membrane decollege, membrane sweep

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What researchers measure

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

    Time frame: Since intervention until 20 hours

Secondary outcomes

  1. Rate of cesarean births

    number of cesarean sections in the patients

    Time frame: Since intervention until 7 days or maternal discharge

  2. Level of Maternal satisfaction

    For the evaluation of the perception of support and birth control, the Mackey MSCRS scale will be used, with a baseline assessment when the patient has cervical dilatation between 0 and 3 cm and a second assessment 24 hours after delivery, there are 35 items, likert scale type, For the evaluation of the perception of support and birth control, the Mackey MSCRS scale will be used, with a baseline assessment when the patient has cervical dilatation between 0 and 3 cm and a second assessment 24 hours after delivery.

    Time frame: Since intervention until 24 hours of delivery or maternal discharge

  3. Rate of maternal complications

    Signs of maternal complications as fever, endometritis

    Time frame: Since intervention until 14 days

07

Study locations

1 site
  • Hospital Escuela
    Tegucigalpa, Francisco Morazán Department 11101, Honduras
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References and documents

Publications

  • 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. PubMed 32103497 ↗

Individual participant data

Plan to share: No — It is not necessary, none of the 18 HIPAA identifiers will be placed

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06809985
Lead sponsor
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
Responsible party
Ricardo A Gutierrez Ramirez, MD, MSc, FACOG (Titular professor, Universidad Nacional Autonoma de Honduras) — Sponsor-investigator
First posted
Feb 5, 2025
Start date
Jan 31, 2025
Primary completion
Jul 31, 2025
Completion
Sep 1, 2025
Last update
Dec 4, 2025

Study contacts

Ricardo A. Gutierrez Ramirez, MD, MSc.
study director · Universidad Nacional Autonoma de Honduras

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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