Prolonged Second Stage of LaborOBY-GELNCT07428317
Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery
A study testing Obstetric Lubricant Gel and Standard Active Management of Second Stage in people with Prolonged Second Stage of Labor, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial summary
This experimental study aims to evaluate whether the application of obstetric lubricant gel during vaginal delivery can significantly reduce the duration of the second stage of labor, preserve perineal integrity, and decrease the need for episiotomies. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolonged Second Stage of Labor
- What is being tested?
- Obstetric Lubricant Gel and Standard Active Management of Second Stage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteHonduras
- Study dates
- 16 Feb 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form
- Willingness to comply with study procedures
- Age between 18 and 40 years
- Term pregnancy (37-41.6 weeks) with active labor
- Diagnosis of spontaneous labor and planned vaginal delivery
- Fetus in cephalic presentation
- Agreement to comply with lifestyle restrictions during the study
Who cannot join
- Multiple pregnancy
- Previous cesarean section
- High-risk pregnancy (preeclampsia, uncontrolled gestational diabetes, etc.)
- Presence of fever or active infection
- Contraindication for vaginal delivery
- Refusal to sign informed consent
Show all 9Show fewer
- Premature rupture of membranes >18 hours without labor
- Known allergy to lubricant gel components
- Participation in another clinical trial in the last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras1 site, 1 recruiting
- Recruiting
Hospital Escuela
Tegucigalpa, Francisco Morazán Department, 11101
Ricardo A Gutierrez-Ramirez, MD, MSc., 97546940, ricardo.gutierrez@unah.edu.hn
María A Delattibodier Perdomo, MD
About this study
Official title: Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial
This experimental study aims to evaluate whether the application of obstetric lubricant gel during vaginal delivery can significantly reduce the duration of the second stage of labor, preserve perineal integrity, and decrease the need for episiotomies. The study hypothesis is that lubricant gel facilitates fetal passage through the birth canal by reducing friction, shortening the expulsion phase and reducing maternal-neonatal complications. Two groups will be included: with and without gel application. Follow-up will span from admission of the pregnant woman until immediate postpartum discharge.
Read the detailed description
This is a single-blind, randomized, parallel-group, controlled clinical trial comparing obstetric lubricant gel application versus standard care during the second stage of labor. The intervention consists of a single 50 mL application of water-based, sterile lubricant gel (e.g., Gynotal®, Dianatal®, or equivalent) into the vaginal canal (anterior and posterior walls) at the onset of the second stage of labor (complete cervical dilation with confirmed cephalic presentation). The control group receives standard obstetric care without lubrication. The primary outcome is duration of the second stage of labor in minutes. Secondary outcomes include perineal integrity (tears, episiotomy), maternal complications (infections, adverse reactions), neonatal Apgar scores at 1 and 5 minutes, and need for instrumental delivery. The study will be conducted at Hospital Materno Infantil, Tegucigalpa, Honduras, with a target enrollment of 160 participants (80 per group). Randomization will be performed using simple block allocation. Statistical analysis will include ANCOVA for the primary outcome, logistic regression for binary secondary outcomes, and appropriate non-parametric tests if assumptions are violated. A Data Safety Monitoring Board (DSMB) will oversee safety every 6 months or after every 20 inclusions.
- Conditions
- Prolonged Second Stage of Labor
- Being tested
- Obstetric Lubricant Gel, Standard Active Management of Second Stage
- Keywords
- Lubricant Gel, Second Stage of Labor, Perineal Integrity, Episiotomy, Vaginal Delivery, Obstetric Gel, Labor Duration, Birth Canal Lubrication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric Lubricant GelOther
A single 50 mL dose of sterile, water-soluble, biocompatible lubricant gel applied intravaginally at the onset of the second stage of labor. The gel is applied to the anterior and posterior vaginal walls using sterile technique to reduce friction during fetal descent and expulsion. The product is used according to its approved indications; no modification has been made for this study. Application is performed by trained medical personnel. In case of local adverse reaction (burning, irritation), application will be discontinued and appropriate clinical management provided.
Standard Active Management of Second StageOther
Standard, evidence-based active management of the second stage of labor according to institutional protocol, without the addition of lubricant gel. This includes continuous maternal-fetal monitoring, supportive care, encouragement of spontaneous pushing, and delivery assistance as per routine practice. All aspects of care are identical to the intervention group except for the application of lubricant gel. This represents the current standard of care against which the experimental intervention is compared.
| Study group | Role | What they receive |
|---|---|---|
| Obstetric Lubricant Gel | Experimental | A single 50 mL dose of sterile, water-soluble, biocompatible lubricant gel applied intravaginally at the onset of the second stage of labor. The gel is applied to the anterior and posterior vaginal walls using sterile technique to reduce friction during fetal descent and expulsion. The product is used according to its approved indications; no modification has been made for this study. Application is performed by trained medical personnel. In case of local adverse reaction (burning, irritation), application will be discontinued and appropriate clinical management provided. Receives: Other: Obstetric Lubricant Gel |
| Standard Active Management of Second Stage | Sham comparator | Standard, evidence-based active management of the second stage of labor according to institutional protocol, without the addition of lubricant gel. This includes continuous maternal-fetal monitoring, supportive care, encouragement of spontaneous pushing, and delivery assistance as per routine practice. All aspects of care are identical to the intervention group except for the application of lubricant gel. This represents the current standard of care against which the experimental intervention is compared. Receives: Other: Standard Active Management of Second Stage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the Second Stage of Labor
Time in minutes from complete cervical dilation (10 cm) to expulsion of the fetus. Measured and recorded by attending obstetric staff using a standardized timer or clock.
Measured: During delivery, from complete cervical dilation until fetal expulsion (approximately 30-120 minutes)
Secondary outcomes (4)
Perineal Integrity
Incidence and severity of perineal tears (classified by degree: 1st, 2nd, 3rd, 4th degree) and performance of episiotomy. Assessed by attending obstetrician immediately after delivery.
Measured: Immediately after delivery
Maternal Complications
Occurrence of adverse events including local irritation, allergic reactions, postpartum hemorrhage, puerperal infection, or any other complication potentially associated with the intervention.
Measured: From intervention until 7 days postpartum
Neonatal Apgar Score
Apgar score assessed at 1 minute and 5 minutes after birth. Score ranges from 0-10, with higher scores indicating better neonatal condition.
Measured: 1 minute and 5 minutes after birth
Need for Instrumental Delivery
Requirement for operative vaginal delivery (forceps, vacuum) or emergency cesarean section during the second stage of labor.
Measured: 30 minutes from intervention During delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start16 Feb 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 Prolonged Second Stage of LaborStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428317
- Sponsor's protocol ID
- PGO-UNAH-49-2-2026
- Acronym
- OBY-GEL
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (anonymized) will be shared for scientific purposes related to maternal-perinatal health. The final dataset will be deposited in the Central American Clinical Data Repository (RCDC) under CC-BY-NC 4.0 license. Only de-identified datasets will be shared, with prior ethics committee approval. Participants may opt in/out during informed consent.
Publications
De Ferrari L, Chiappori A, Bagnasco D, Riccio AM, Passalacqua G, Canonica GW. Molecular phenotyping and biomarker development: are we on our way towards targeted therapy for severe asthma? Expert Rev Respir Med. 2016;10(1):29-38. doi: 10.1586/17476348.2016.1111763. Epub 2015 Nov 13.
PubMed 26566089
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Lubricant Gel to Shorten the Second Stage of Labor During Vaginal Delivery: A Randomized Single-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07428317
- Acronym / sponsor ID
- OBY-GEL / PGO-UNAH-49-2-2026
- Conditions
- Prolonged Second Stage of Labor
- Keywords
- Lubricant Gel, Second Stage of Labor, Perineal Integrity, Episiotomy, Vaginal Delivery, Obstetric Gel, Labor Duration, Birth Canal Lubrication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de HondurasUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Feb 2026 (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.
This experimental study aims to evaluate whether the application of obstetric lubricant gel during vaginal delivery can significantly reduce the duration of the second stage of labor, preserve perineal integrity, and decrease the need for episiotomies. The study hypothesis is that lubricant gel facilitates fetal passage through the birth canal by reducing friction, shortening the expulsion phase and reducing maternal-neonatal complications. Two groups will be included: with and without gel application. Follow-up will span from admission of the pregnant woman until immediate postpartum discharge.
Detailed description
This is a single-blind, randomized, parallel-group, controlled clinical trial comparing obstetric lubricant gel application versus standard care during the second stage of labor. The intervention consists of a single 50 mL application of water-based, sterile lubricant gel (e.g., Gynotal®, Dianatal®, or equivalent) into the vaginal canal (anterior and posterior walls) at the onset of the second stage of labor (complete cervical dilation with confirmed cephalic presentation). The control group receives standard obstetric care without lubrication. The primary outcome is duration of the second stage of labor in minutes. Secondary outcomes include perineal integrity (tears, episiotomy), maternal complications (infections, adverse reactions), neonatal Apgar scores at 1 and 5 minutes, and need for instrumental delivery. The study will be conducted at Hospital Materno Infantil, Tegucigalpa, Honduras, with a target enrollment of 160 participants (80 per group). Randomization will be performed using simple block allocation. Statistical analysis will include ANCOVA for the primary outcome, logistic regression for binary secondary outcomes, and appropriate non-parametric tests if assumptions are violated. A Data Safety Monitoring Board (DSMB) will oversee safety every 6 months or after every 20 inclusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstetric Lubricant Gel | Experimental | Other: Obstetric Lubricant GelA single 50 mL dose of sterile, water-soluble, biocompatible lubricant gel applied intravaginally at the onset of the second stage of labor. The gel is applied to the anterior and posterior vaginal walls using sterile technique to reduce friction during fetal descent and expulsion. The product is used according to its approved indications; no modification has been made for this study. Application is performed by trained medical personnel. In case of local adverse reaction (burning, irritation), application will be discontinued and appropriate clinical management provided. |
| Standard Active Management of Second Stage | Sham comparator | Other: Standard Active Management of Second StageStandard, evidence-based active management of the second stage of labor according to institutional protocol, without the addition of lubricant gel. This includes continuous maternal-fetal monitoring, supportive care, encouragement of spontaneous pushing, and delivery assistance as per routine practice. All aspects of care are identical to the intervention group except for the application of lubricant gel. This represents the current standard of care against which the experimental intervention is compared. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Signed informed consent form
- Willingness to comply with study procedures
- Age between 18 and 40 years
- Term pregnancy (37-41.6 weeks) with active labor
- Diagnosis of spontaneous labor and planned vaginal delivery
Key exclusion criteria (9 listed)
- Multiple pregnancy
- Previous cesarean section
- High-risk pregnancy (preeclampsia, uncontrolled gestational diabetes, etc.)
- Presence of fever or active infection
- Contraindication for vaginal delivery
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 |
|---|---|---|
| Obstetric Lubricant GelA single 50 mL dose of sterile, water-soluble, biocompatible lubricant gel applied intravaginally at the onset of the second stage of labor. The gel is applied to the anterior and posterior vaginal walls using sterile technique to reduce friction during fetal descent and expulsion. The product is used according to its approved indications; no modification has been made for this study. Application is performed by trained medical personnel. In case of local adverse reaction (burning, irritation), application will be discontinued and appropriate clinical management provided. | Other | Obstetric Lubricant Gel |
| Standard Active Management of Second StageStandard, evidence-based active management of the second stage of labor according to institutional protocol, without the addition of lubricant gel. This includes continuous maternal-fetal monitoring, supportive care, encouragement of spontaneous pushing, and delivery assistance as per routine practice. All aspects of care are identical to the intervention group except for the application of lubricant gel. This represents the current standard of care against which the experimental intervention is compared. | Other | Standard Active Management of Second Stage |
Primary outcome
Duration of the Second Stage of Labor
Time frame: During delivery, from complete cervical dilation until fetal expulsion (approximately 30-120 minutes)
Time in minutes from complete cervical dilation (10 cm) to expulsion of the fetus. Measured and recorded by attending obstetric staff using a standardized timer or clock.
4 secondary outcomes
Perineal Integrity
Time frame: Immediately after delivery
Maternal Complications
Time frame: From intervention until 7 days postpartum
Neonatal Apgar Score
Time frame: 1 minute and 5 minutes after birth
Need for Instrumental Delivery
Time frame: 30 minutes from intervention During delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 26566089De Ferrari L, Chiappori A, Bagnasco D, Riccio AM, Passalacqua G, Canonica GW. Molecular phenotyping and biomarker development: are we on our way towards targeted therapy for severe asthma? Expert Rev Respir Med. 2016;10(1):29-38. doi: 10.1586/17476348.2016.1111763. Epub 2015 Nov 13.
- Individual participant dataSharing planned: Undecided. Individual participant data (anonymized) will be shared for scientific purposes related to maternal-perinatal health. The final dataset will be deposited in the Central American Clinical Data Repository (RCDC) under CC-BY-NC 4.0 license. Only de-identified datasets will be shared, with prior ethics committee approval. Participants may opt in/out during informed consent.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstetric Lubricant Gel and Standard Active Management of Second Stage in people with Prolonged Second Stage of Labor, run by Universidad Nacional Autonoma de Honduras 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 7 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo A Gutierrez-Ramirez, MD, MSc (+50497546940, ricardo.gutierrez@unah.edu.hn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the Second Stage of Labor (time frame: During delivery, from complete cervical dilation until fetal expulsion (approximately 30-120 minutes)). 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 NCT07428317, 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 23 Feb 2026.