Clinical trial NCT06809985: Latent Phase Membrane Stripping for Caesarean Section Reduction
Official title: Latent Phase Membrane Stripping for Caesarean Section Reduction. Single Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Delivery
Cervical Ripening
Latent Phase Labour
Keywords: Cesarean Delivery
Cervical ripening
latent phase labour
hamilton maneuver
Lead sponsor: Universidad Nacional Autonoma de Honduras
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.
Primary purpose: PREVENTION

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.

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 greater 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

Primary outcomes:
measure: Time from admission until active phase
timeFrame: Since intervention until 20 hours
Secondary outcomes:
measure: Rate of cesarean births
timeFrame: Since intervention until 7 days or maternal discharge
measure: Level of Maternal satisfaction
timeFrame: Since intervention until 24 hours of delivery or maternal discharge
measure: Rate of maternal complications
timeFrame: Since intervention until 14 days
Other outcomes:
Locations:
city: Tegucigalpa
country: Honduras
facility: Hospital Escuela
state: Francisco Morazán
Study officials:
affiliation: Universidad Nacional Autonoma de Honduras
name: Ricardo A. Gutierrez Ramirez, MD, MSc.
role: STUDY_DIRECTOR
References:
citation: 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.