Labor Stage, Second Clinical Trial
Official title:
Obstetrical Gel Use to Shorten Labor and Prevent Lower Genital Tract Trauma: A Randomized Controlled Trial
Verified date | September 2020 |
Source | American University of Beirut Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 28, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Lebanon | Amercian University of Beirut Medical Center | Beirut |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Lebanon,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Second stage of labor, a reduction to 39.9 minutes from a calculated average of 66.5 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01242293 -
Intrapartum Hydration
|
N/A |