Clinical trial NCT04807543: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Preterm Premature Rupture of Membrane
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

1. 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.
2. 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.
3. 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.

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

Primary outcomes:
measure: prolongation of the pregnancy until a favorable gestational age
timeFrame: 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 outcomes:
measure: Latency .
timeFrame: 10 to 12 weeks (interval in weeks from randomization to delivery)
measure: Composite neonatal morbidity
timeFrame: 1 week (from delivery to 1 week post Natal)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References: