Cesarean DeliveryDEMEMNCT06809985
Latent Phase Membrane Stripping for Caesarean Section Reduction
A study testing Hamilton maneuver in people with Cesarean Delivery and Cervical Ripening, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery, Cervical Ripening, Latent Phase Labour
- What is being tested?
- Hamilton maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteHonduras
- Study dates
- 31 Jan 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Previous uterine surgery
- Maternal condition preventing vaginal delivery
- Fetal anomaly
- Premature rupture of membranes
- Multiple pregnancy
- Fetal orbit
Show all 9Show fewer
- Myomas
- Maternal comorbidities such as chronic arterial hypertension, type 1, 2 and gestational diabetes, hypothyroidism, among others.
- Anemia
Trial locations and contacts
1 site in 1 country.
Honduras1 site
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
About this study
Official title: Latent Phase Membrane Stripping for Caesarean Section Reduction. Single Blind Clinical Trial
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.
- Conditions
- Cesarean Delivery, Cervical Ripening, Latent Phase Labour
- Being tested
- Hamilton maneuver
- Keywords
- Cesarean Delivery, Cervical ripening, latent phase labour, hamilton maneuver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamilton maneuverProcedure or surgery
Also called membrane decollege, membrane sweep
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from admission until active phase
time from the intervention to reach a cervical dilatation greater than or equal to 5 cm
Measured: Since intervention until 20 hours
Secondary outcomes (3)
Rate of cesarean births
number of cesarean sections in the patients
Measured: Since intervention until 7 days or maternal discharge
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.
Measured: Since intervention until 24 hours of delivery or maternal discharge
Rate of maternal complications
Signs of maternal complications as fever, endometritis
Measured: Since intervention until 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start31 Jan 2025
- Primary completion31 Jul 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
- Investigators
- Ricardo A. Gutierrez Ramirez, MD, MSc., Study director, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809985
- Sponsor's protocol ID
- PGO-UNAH-48-6-2025
- Acronym
- DEMEM
- Status last verified
- Sep 2025
- First submitted
- 15 Jan 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not necessary, none of the 18 HIPAA identifiers will be placed
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latent Phase Membrane Stripping for Caesarean Section Reduction. Single Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06809985
- Acronym / sponsor ID
- DEMEM / PGO-UNAH-48-6-2025
- Conditions
- Cesarean Delivery, Cervical Ripening, Latent Phase Labour
- Keywords
- Cesarean Delivery, Cervical ripening, latent phase labour, hamilton maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ricardo A Gutierrez Ramirez, MD, MSc, FACOGUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind, parallel-group, efficacy, superiority, single-blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Hamilton maneuver | Experimental | Procedure: Hamilton maneuverThe 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 | No intervention | –A normal gynecological evaluation will be performed, no additional maneuvers will be performed in addition to the routine evaluation of the patient. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- Previous uterine surgery
- Maternal condition preventing vaginal delivery
- Fetal anomaly
- Premature rupture of membranes
- Multiple pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hamilton maneuverAlso: membrane decollege, membrane sweepThe 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 or surgery | Hamilton maneuver |
Primary outcome
Time from admission until active phase
Time frame: Since intervention until 20 hours
time from the intervention to reach a cervical dilatation greater than or equal to 5 cm
3 secondary outcomes
Rate of cesarean births
Time frame: Since intervention until 7 days or maternal discharge
Level of Maternal satisfaction
Time frame: Since intervention until 24 hours of delivery or maternal discharge
Rate of maternal complications
Time frame: Since intervention until 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 32103497Finucane 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.
- Individual participant dataSharing planned: No. It is not necessary, none of the 18 HIPAA identifiers will be placed
Related trials for Cesarean Delivery
Recruiting
Post-Operative Cesarean Section Cosmesis
Cesarean Delivery
RecruitingPhase 4
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
Complex Obstetric Surgery, Perioperative Pain Management
Not yet recruiting
Comparison of HPI-guided Norepinephrine Boluses, ClearSight-guided Norepinephrine Infusion, and Oscillometric-guided Norepinephrine Infusion for Blood Pressure Stability During Cesarean Delivery
Hypotension During Cesarean Delivery, Blood Pressure Monitoring
RecruitingObservational study
Pupillary Light Reflex to Predict Post-Spinal Hypotension in Elective Cesarean Delivery
Hypotension, Spinal Anesthesia
RecruitingPhase 4
BUprenorphine Versus Morphine for Postcesarean Analgesia (BUMP)
Cesarean Delivery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo A. Gutierrez Ramirez, MD, MSc. study director
Universidad Nacional Autonoma de Honduras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hamilton maneuver in people with Cesarean Delivery and Cervical Ripening, run by Ricardo A Gutierrez Ramirez, MD, MSc, FACOG at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from admission until active phase (time frame: Since intervention until 20 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06809985, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.