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

Preterm Premature Rupture of Membrane Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04807543
• Other study ID #: ppprom
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2018
• Est. completion date: December 10, 2020

Study information

• Verified date: March 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 10, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

Drug:
• 17-hydroxyprogesterone caproate
intramuscular injection weekly
• Castor Oil
intramuscular injection weekly

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prolongation of the pregnancy until a favorable gestational age	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	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	Latency .	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	10 to 12 weeks (interval in weeks from randomization to delivery)
Secondary	Composite neonatal morbidity	by Apgar score ,blood gases ,and labs	1 week (from delivery to 1 week post Natal)