Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa

Study Overview
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Brief Summary
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Purpose to evaluate the effects of Vaginal Progesterone versus 17-Alpha-Hydroxyprogesterone Caproate for prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women with Placenta Previa

Detailed Description
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The study will be a randomized open-label clinical trial conducted at a tertiary university hospital outpatient clinic and some private settings at Aswan governorate, Egypt, between January 2019 and March 2022. The authors will include women who asymptomatic pregnant women with a diagnosed placenta previa at 26-28 weeks gestation. They will be randomized into three groups: group I (vaginal progesterone suppositories ), group II (received an intramuscular dose of 250 mg 17-alpha-Hydroxyprogesterone caproate(17-OHPC) once a week) and group III(control group). In each group, Follow-up visits were performed every week then admission was done at 36 weeks at our university hospital. Scheduled caesarian section was done at completed 37 weeks unless otherwise required.

Official Title
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Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Asymptomatic Pregnant Women With Placenta Previa: A Randomized Controlled Study

Conditions
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Placenta Previa

Intervention / Treatment
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* Drug: 17-OHPC
* Drug: vaginal progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age 26-28 weeks of gestation. Definite and reliable diagnosis of placenta previa (defined as the presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan Exclusion Criteria: Multiple pregnancies. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabour rupture of the membranes (PPROM). Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent -intervention and delivery. Women who have been maintained on progestin therapy since early pregnancy for whatever reason.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 17-OHPC<br>patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery | Drug: 17-OHPC<br>* received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery.<br>* Other names: cidolut depot;|
| Active Comparator: vaginal progesterone<br>vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily at bedtime starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery | Drug: vaginal progesterone<br>* vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery<br>* Other names: Cyclogest;|
| No Intervention: control group<br>Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patient delivered before 37 weeks | calculation the number of patients delivered before 37 weeks | 2 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of episodes of antepartum hemorrhage | calculating the mean number of episodes of antepartum hemorrhage | 2 month | 
| Hospital admission for significant antepartum hemorrhage | Number of patients requiring hospital admission for significant antepartum hemorrhage | 2 month | 
| Neonatal Birth weight | measure Neonatal Birth weight in kilograms | one hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, placenta previa, antepartum hemorrhage, vaginal progesterone, 17-Alpha-Hydroxyprogesterone Caproate