Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
Primary Purpose
Preterm Premature Rupture of Membrane
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
17-hydroxyprogesterone caproate
Castor Oil
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Premature Rupture of Membrane
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancy
- Gestational age between 24 and 34 weeks
Exclusion Criteria:
Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as
- Emergency Cesarean section.
- Chorioamnionitis.
- Placenta previa.
- Multiple gestation.
- Preeclampsia.
- Macrosomia.
- Non reassuring fetal status or fetal distress
- Presence of fetal anomalies incompatable with life
- Woman with antepartum haemorrhage
- Diagnosis of Established preterm labor
Sites / Locations
- Ain shams university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
study group
control group
Arm Description
17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection
castor oil, 1 mL total volume intramuscular injection
Outcomes
Primary Outcome Measures
prolongation of the pregnancy until a favorable gestational age
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Secondary Outcome Measures
Latency .
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Composite neonatal morbidity
by Apgar score ,blood gases ,and labs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04807543
Brief Title
Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
Official Title
Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.
Detailed Description
After taking informed written consent, the recruited patients will be subjected to the following:
Detailed history
Personal History: Name, age ,residence ,special habits of medical importance
Obstetric history: first day of last menstrual period for accurate estimation of gestational age and antenatal care
Past history: history of any medical disorder or surgical history with particular emphasis on prior PPROM or preterm labor
History of the present pregnancy: Medical or surgical condition to define high risk pregnancy.
Examination of the patients General examination: blood pressure, pulse, temperature
Abdominal examination:
Inspection: fundal level, scars, umbilicus.
Palpation: presence of contractions, fetal lie and presentation.
Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement
Non stress test to ensure reassuring fetal well being
Ultrasound examination to:-
Assess fetal viability.
Amniotic fluid index.
Determine gestational age.
Exclude major anomalies.
Placental location.
Baseline laboratory investigations:
Complete blood count (CBC).
Prothrombin time (PT).
Activated partial thromboplastin time (aPTT).
Liver and kidney function.
The included patients were randomized using sealed opaque envelope method into one of two groups:
Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume, intramuscular injection weekly) will be administered.
Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will be administered.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Membrane
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Active Comparator
Arm Description
17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
castor oil, 1 mL total volume intramuscular injection
Intervention Type
Drug
Intervention Name(s)
17-hydroxyprogesterone caproate
Intervention Description
intramuscular injection weekly
Intervention Type
Drug
Intervention Name(s)
Castor Oil
Intervention Description
intramuscular injection weekly
Primary Outcome Measure Information:
Title
prolongation of the pregnancy until a favorable gestational age
Description
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Time Frame
10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)
Secondary Outcome Measure Information:
Title
Latency .
Description
The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used
Time Frame
10 to 12 weeks (interval in weeks from randomization to delivery)
Title
Composite neonatal morbidity
Description
by Apgar score ,blood gases ,and labs
Time Frame
1 week (from delivery to 1 week post Natal)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Singleton pregnancy
Gestational age between 24 and 34 weeks
Exclusion Criteria:
Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as
Emergency Cesarean section.
Chorioamnionitis.
Placenta previa.
Multiple gestation.
Preeclampsia.
Macrosomia.
Non reassuring fetal status or fetal distress
Presence of fetal anomalies incompatable with life
Woman with antepartum haemorrhage
Diagnosis of Established preterm labor
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
11591
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
starting 6 months after publication
Learn more about this trial
Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
We'll reach out to this number within 24 hrs