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Completed

NCT Number: NCT04807543

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

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ain shams university

Cairo, 11591, Egypt

About this study

After taking informed written consent, the recruited patients will be subjected to the following:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

17-hydroxyprogesterone caproate

Drug

intramuscular injection weekly

Castor Oil

Drug

intramuscular injection weekly

Primary outcomes

  1. prolongation of the pregnancy until a favorable gestational age

    Time frame: 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)

    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

Secondary outcomes

  1. Latency .

    Time frame: 10 to 12 weeks (interval in weeks from randomization to delivery)

    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

  2. Composite neonatal morbidity

    Time frame: 1 week (from delivery to 1 week post Natal)

    by Apgar score ,blood gases ,and labs

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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