Clinical trial NCT03537287: Different Types of Progesterone in the Prevention of Preterm Labor
Official title: Intramuscular 17Alpha-hydroxyprogestrone, Progesterone Suppositories and Dydrogesterone Tablets in Preventing Preterm Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Preterm Labor
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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

Group 1:

Women who will take intramuscular 17 alpha hydroxyprogestrone caproate

Dose:

250 mg intramuscularly, once weekly starting from 16 weeks till delivery or 36 weeks.

Group 2 :

Women who will take progesterone 200mg vaginal suppositories.

Dose:

Once per day starting from 16 weeks till delivery or 36 weeks

Group 3 :

Women who will take oral dydrogesterone

Dose:

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.

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Living fetus with gestational age 16-18weeks (calculated according to date of last menstrual period confirmed with earlier ultrasound examination).
* Presence of risk factor for preterm labor:

  1. Previous spontaneous preterm labor in previous singleton Pregnancy, OR
  2. Previous spontaneous second trimestric miscarriage less than 3 times, OR
  3. Short cervix less than 25mm diagnosed during midtrimesteric transvaginal ultrasound examination at 16-18 weeks with or without history of previous preterm labor.

Exclusion Criteria:

* Multiple pregnancy.
* Medical or obstetric conditions requiring termination of pregnancy
* Contraindication to progesterone administration or its use earlier in this pregnancy

  * Current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy.
  * Liver dysfunction or disease.
  * Known or suspected malignancy of breast or genital organs.
  * Undiagnosed vaginal bleeding.
  * Missed abortion.
  * Known sensitivity to progesterone injection.
  * Known sensitivity to sesame oil/seeds.
* Congenital fetal anomalies
* Cervical cerclage in the current pregnancy.
* Presence of uterine anomalies (Unicornuate uterus , Uterus didelphys, bicornuate uterus,Septated uterus) or uterine fibroid.
* Presence of history of chronic hypertetion, chronic liver or kidney diseases, and pregnancy induced hypertension.

Primary outcomes:
measure: Gestational age in weeks at delivery.
timeFrame: 6 months
Secondary outcomes:
measure: Hemodynamic changes in fetoplacental circulation
timeFrame: 6 months
measure: Unsatisfactory response
timeFrame: 6 months
measure: Failure of prevention of preterm labor
timeFrame: 6 months
measure: Birth weight
timeFrame: 6 months
measure: Neonatal APGAR score
timeFrame: 6 months
measure: Need for NICU admission
timeFrame: 6 months
measure: Neonatal mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain SHams Maternity Hospital
state: Abbaseya
Study officials:
affiliation: M Samy
name: Mohamed Samy, MD
role: PRINCIPAL_INVESTIGATOR
References: