17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa

Study Overview
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Brief Summary
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Purpose to evaluate the effects of intramuscular 17-Alpha-Hydroxyprogesterone Caproate (17-OHPC) for prevention of Emergent Cesarean Delivery in symptomatic Pregnant Women with Placenta Previa

Detailed Description
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Most authors report an increased risk of bleeding with advancing gestation among women with placenta previa. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) both recommend the use of 17-OHPC to prevent recurrent spontaneous preterm birth. Preterm deliveries account for 75% of perinatal mortality and surviving preterm infants are at risk for neurological, respiratory, and gastrointestinal complications. So, it is therefore very important to try to prolong the pregnancy without increasing the risk of emergent delivery in cases with placenta previa. The authors hypothesized that a pharmacological strategy like 17-alpha-Hydroxyprogesterone caproate may improve pregnancy outcomes and may also allow obstetricians to tailor their approach to save delayed scheduled cesarean section women with a placenta previa. The aim of this study to evaluate the role of17-alpha-Hydroxyprogesterone caproate in the prevention of preterm cesarean delivery (CD) in cases with symptomatic placenta previa with avoids of an emergent CD which affects the maternal outcome and prevents prematurity which affects the prenatal outcome.

Official Title
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Intramuscular 17-Alpha-Hydroxyprogesterone Caproate for Prevention of Emergent Cesarean Delivery in Symptomatic 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: placebo to 17-OHPC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Estimated gestational age: between 24 weeks and 37 week's gestation Confirmed Placenta previa; either major or minor degrees. Placenta previa with preterm uterine contractions or with a history of at least single attack of mild vaginal bleeding Exclusion Criteria: Severe attack of bleeding requiring an immediate intervention. Fetal heart rates instability or non-reassuring tracing Intrauterine fetal death or major fetal anomalies. If associated with abruptio placentae Patients with known bleeding disorders or on anticoagulant therapy Patients with severe medical disorders

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 Double-Blind Randomized Clinical Trial
Masking: Quadruple


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 24-26 week and up to 37-weeks' gestation or delivery | Drug: 17-OHPC<br>* patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery<br>* Other names: cidolut depot;|
| Placebo Comparator: placebo to 17-OHPC<br>patients received weekly placebo to 17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery | Drug: placebo to 17-OHPC<br>* patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery<br>* Other names: Placebo Comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the duration of prolongation of pregnancy from the time of enrollment to the time of delivery | measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apgar score | measure apgar score from 0 to 10 | 5 minutes postpartum | 
| the number of patients with postpartum hemorrhage | calculation the number of patients with postpartum hemorrhage | 24 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, 17-alpha-Hydroxyprogesterone caproate