Labor Stage, SecondPhase 4NCT03518684
Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma
A Phase 4 study testing Natalis in people with Labor Stage, Second, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Stage, Second
- What is being tested?
- Natalis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteLebanon
- Study dates
- 3 Apr 2018to 30 Jun 2019
- Phase
- Phase 4
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years
- Intended vaginal delivery
- Singleton baby in vertex presentation
- Low risk pregnancy at term (37-42 weeks of gestation)
- Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
- Signed written informed consent
Who cannot join
- Contraindications for vaginal delivery (placenta previa, active herpes infection, etc…)
- Advanced cervical dilation (≥ 5 cm)
- Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain)
- Non reassuring fetal heart tracing
- Prolonged rupture of the membranes (24 hours)
- Suspected major fetal malformations
- Suspected cephalopelvic disproportion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial
Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. In addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. In an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated.
The objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract. Neonatal and maternal morbidities will be also assessed.
Read more
The study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either:
- Group 1 who will receive the standard care during labor and delivery
- Group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel The goal of this randomized controlled study is to compare the length of the first and 2nd stage of labor and the lower genital tract integrity in the 2 groups of patients.
- Conditions
- Labor Stage, Second
- Being tested
- Natalis
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalisDrug
A specially-designed sterile obstetric gel (Natalis) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that has a purely physical activity. It contains propylene glycol, glycerol, sodium chloride, xanthan gum, hydroxyethylcellulose and water.
Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child using the sterile obstetric gel applicator without any manipulation or massaging. Additional obstetric gel will be added 15-30 minutes after rupture of the membranesOnce the head of the child is visible, the mouth and nose region will be wiped clean. A dry towel will be used to liberate the child in order to prevent the child from slipping
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel |
| Group 2 | Experimental | Group 2 in which they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel according to the study protocol. Those 2 groups will be further divided into 4 subgroups where the parity will be accounted for (nulliparous [never delivered beyond 20 weeks of gestation in a previous pregnancy] or primiparous or more) Receives: Drug: Natalis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the length of the second stage of labor
40% reduction in the duration of the second stage of labor with a calculated average duration of 66.5 min. Thus a reduction to 39.9 minutes for every patient recruited
Measured: Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start3 Apr 2018
- Primary completion28 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor Stage, SecondStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this randomized controlled study, the patients will be randomly assigned to either Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel or Group 2 in which they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel according to the study protocol. Those 2 groups will be further divided into 4 subgroups where the parity will be accounted for (nulliparous \[never delivered beyond 20 weeks of gestation in a previous pregnancy\] or primiparous or more). Based on our departmental statistics, \~90% of laboring patients receive epidural. Hence receiving an epidural will not have a major impact on the duration of the second stage of labor; yet, whether the patient received epidural or not will be adjusted for.
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elie Hobeika, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518684
- Sponsor's protocol ID
- OGY.EH.03
- Status last verified
- Sep 2020
- First submitted
- 16 Apr 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03518684
- Acronym / sponsor ID
- OGY.EH.03
- Conditions
- Labor Stage, Second
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 8 May 2018 (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.
Recent literature shows that birth injury is associated with postpartum pelvic floor dysfunction (pelvic organ prolapse and fecal and urinary incontinence). Prolonged labor, namely during the 2nd stage, is one of the main obstetric risk factors responsible for anal sphincter rupture and fecal incontinence. In addition, it is associated with increased maternal and neonatal morbidities including increased risk of lower genital tract lacerations. In an effort to shorten labor and decrease lower genital tract trauma many techniques have been investigated.
The objective of our study is to investigate whether the use of obstetric gel shortens the first and second stage of labor and exerts a protective effect on the lower genital tract. Neonatal and maternal morbidities will be also assessed.
The study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either:
- Group 1 who will receive the standard care during labor and delivery
- Group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel The goal of this randomized controlled study is to compare the length of the first and 2nd stage of labor and the lower genital tract integrity in the 2 groups of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this randomized controlled study, the patients will be randomly assigned to either Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel or Group 2 in which they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel according to the study protocol. Those 2 groups will be further divided into 4 subgroups where the parity will be accounted for (nulliparous [never delivered beyond 20 weeks of gestation in a previous pregnancy] or primiparous or more). Based on our departmental statistics, ~90% of laboring patients receive epidural. Hence receiving an epidural will not have a major impact on the duration of the second stage of labor; yet, whether the patient received epidural or not will be adjusted for.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Group 1 in which they will receive the standard care during labor and delivery without the use of the obstetrical gel |
| Group 2 | Experimental | Drug: NatalisGroup 2 in which they will have the standard care during labor and delivery with the vaginal application of the obstetrical gel according to the study protocol. Those 2 groups will be further divided into 4 subgroups where the parity will be accounted for (nulliparous [never delivered beyond 20 weeks of gestation in a previous pregnancy] or primiparous or more) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 40 years
- Intended vaginal delivery
- Singleton baby in vertex presentation
- Low risk pregnancy at term (37-42 weeks of gestation)
- Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
Key exclusion criteria (7 listed)
- Contraindications for vaginal delivery (placenta previa, active herpes infection, etc…)
- Advanced cervical dilation (≥ 5 cm)
- Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain)
- Non reassuring fetal heart tracing
- Prolonged rupture of the membranes (24 hours)
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 |
|---|---|---|
| NatalisA specially-designed sterile obstetric gel (Natalis) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that has a purely physical activity. It contains propylene glycol, glycerol, sodium chloride, xanthan gum, hydroxyethylcellulose and water. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child using the sterile obstetric gel applicator without any manipulation or massaging. Additional obstetric gel will be added 15-30 minutes after rupture of the membranesOnce the head of the child is visible, the mouth and nose region will be wiped clean. A dry towel will be used to liberate the child in order to prevent the child from slipping | Drug | Group 2 |
Primary outcome
Reduction in the length of the second stage of labor
Time frame: Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes
40% reduction in the duration of the second stage of labor with a calculated average duration of 66.5 min. Thus a reduction to 39.9 minutes for every patient recruited
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 3 Sep 2020.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Natalis in people with Labor Stage, Second, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 6 inclusion and 7 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 3 Sep 2020. 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 Lebanon. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Reduction in the length of the second stage of labor (time frame: Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Sep 2020.