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.

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

Preterm Premature Rupture of Membrane

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.

17-hydroxyprogesterone caproate

Castor Oil

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

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

castor oil, 1 mL total volume intramuscular injection

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status