Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes

Ain Shams University

Status and phase: Completed; Phase 2

Conditions: Preterm Premature Rupture of Membrane

Treatments: Drug: 17-hydroxyprogesterone caproate; Drug: Castor Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04807543

ppprom

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups, including a placebo group

study group

Active Comparator group

Description:

17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection

Treatment:

Drug: 17-hydroxyprogesterone caproate

control group

Placebo Comparator group

Description:

castor oil, 1 mL total volume intramuscular injection

Treatment:

Drug: Castor Oil