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

• ClinicalTrials.gov Identifier: NCT04807543
• Recruitment Status: Completed
• First Posted: March 19, 2021
• Last Update Posted: March 19, 2021
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Preterm Premature Rupture of Membrane	Drug: 17-hydroxyprogesterone caproate; Drug: Castor Oil	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
• Actual Study Start Date: January 10, 2018
• Actual Primary Completion Date: October 10, 2020
• Actual Study Completion Date: December 10, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: study group; 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection	Drug: 17-hydroxyprogesterone caproate; intramuscular injection weekly
Placebo Comparator: control group; castor oil, 1 mL total volume intramuscular injection	Drug: Castor Oil; intramuscular injection weekly

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Egypt

Ain shams university

Cairo, Egypt, 11591

Sponsors and Collaborators

Ain Shams University

More Information

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT04807543
• Other Study ID Numbers: ppprom
• First Posted: March 19, 2021
• Last Update Posted: March 19, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code
• Time Frame: starting 6 months after publication

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Premature Birth; Fetal Membranes, Premature Rupture; Rupture; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Wounds and Injuries; Castor Oil; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Progestins; Hormones; Cathartics; Gastrointestinal Agents