Different Types of Progesterone in the Prevention of Preterm Labor
|ClinicalTrials.gov Identifier: NCT03537287|
Recruitment Status : Unknown
Verified May 2018 by mohammed mahmoud samy, Ain Shams University.
Recruitment status was: Recruiting
First Posted : May 25, 2018
Last Update Posted : May 29, 2018
Preterm birth is a common problem in obstetric care,with estimates ranging from 5% in several European countries to 18% in some African countries, Preterm labor defined as delivery before 37 completed weeks is the leading cause of perinatal and neonatal morbidity and mortality and strongly related to the developmental and neurological disabilities later in life..
There is still considerable uncertainty regarding the optimal progesterone type, route of administration, dosage and timing of start of therapy to prevent preterm labor in risky women
|Condition or disease||Intervention/treatment||Phase|
|Preterm Labor||Drug: 17 alpha hydroxyprogestrone caproate Drug: Vaginal progesterone Drug: Oral dydrogesterone||Phase 2|
This study aims to compare between the efficacy of intramuscular 17alpha-hydroxyprogestrone, progesterone vaginal suppositories and dydrogesterone oral tablets in prevention of preterm labor in high risk women.
All women will be counseled regarding mode of intervention and informed consent will be obtained. All cases will be subjected to complete history taking, routine antenatal examination and investigations, treatment of genital or urinary tract infections if diagnosed. Routine obstetric ultrasound examination and measurement of cervical length by transvaginal ultrasound will be carried out at 16-18weeks of pregnancy.
The study population will be randomly distributed according to the mode of intervention into 3 groups.
Randomization is performed using a Computer-generated randomization system. Blinding of the intervention is not feasible in this trial (owing to the different route of administration of the studied drugs).Table of randomization is obtained
Women who will take intramuscular 17 alpha hydroxyprogestrone caproate
250 mg intramuscularly, once weekly starting from 16 weeks till delivery or 36 weeks.
Group 2 :
Women who will take progesterone 200mg vaginal suppositories.
Once per day starting from 16 weeks till delivery or 36 weeks
Group 3 :
Women who will take oral dydrogesterone
Take 2 tablets a day starting from 16 weeks till delivery or 36 weeks
Color Doppler blood flow velocity examination of fetal circulation will be performed by an independent investigator blinded to treatment before treatment &after two weeks of treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intramuscular 17Alpha-hydroxyprogestrone, Progesterone Suppositories and Dydrogesterone Tablets in Preventing Preterm Labor|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||August 2018|
Active Comparator: 17 alpha hydroxyprogestrone caproate Group
Patients will receive 250 mg of 17 alpha hydroxyprogestrone caproate intramuscularly once weekly starting from 16 weeks till delivery or 36 weeks.
Drug: 17 alpha hydroxyprogestrone caproate
250 mg of 17 alpha hydroxyprogestrone caproate weekly
Active Comparator: Vaginal progesterone Group
Patients will receive vaginal progesterone 200 mg once per day starting from 16 weeks till delivery or 36 weeks.
Drug: Vaginal progesterone
200 mg of vaginal progesterone daily
Active Comparator: Oral dydrogesterone Group
Patients will receive 2 tablets of oral dydrogesterone daily starting from 16 weeks till delivery or 36 weeks
Drug: Oral dydrogesterone
2 tablets of dydrogesterone daily
- Gestational age in weeks at delivery. [ Time Frame: 6 months ]using either the last menstrual period in patients with regular cycles or early first trimester ultrasound to calculate the gestational age in weeks at delivery
- Hemodynamic changes in fetoplacental circulation [ Time Frame: 6 months ]Measurement of U/S Doppler indices of umbilical artery and middle cerebral artery (namely PI, RI and S/D ratio) in fetal circulation
- Unsatisfactory response [ Time Frame: 6 months ]Number of patients who needed to increase the dose above the recommended initial dose.
- Failure of prevention of preterm labor [ Time Frame: 6 months ]Number of patients who suffered preterm labor and needed tocolysis
- Birth weight [ Time Frame: 6 months ]Birth weight in Kg
- Neonatal APGAR score [ Time Frame: 6 months ]Neonatal Apgar score at 1 and 5 min.
- Need for NICU admission [ Time Frame: 6 months ]
Number of patients whose neonates were admitted to NICU
- Neonatal mortality [ Time Frame: 6 months ]Number of neonatal deaths
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537287
|Contact: Mohamed Samy, MDemail@example.com|
|Ain SHams Maternity Hospital||Recruiting|
|Cairo, Abbaseya, Egypt|
|Contact: Mohamed Samy, MD|
|Principal Investigator:||Mohamed Samy, MD||M Samy|