Placenta Previa
Conditions
Keywords
cesarean section, placenta previa, antepartum hemorrhage, 17-alpha-Hydroxyprogesterone caproate
Brief summary
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
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.
Interventions
DRUG17-OHPC
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
DRUGplacebo to 17-OHPC
patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A Double-Blind Randomized Clinical Trial
Intervention model description
A Double-Blind Randomized Clinical Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the duration of prolongation of pregnancy from the time of enrollment to the time of delivery | 6 weeks | measure the duration of prolongation of pregnancy in days measured from the time of enrollment to the time of delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| apgar score | 5 minutes postpartum | measure apgar score from 0 to 10 |
| the number of patients with postpartum hemorrhage | 24 hours post operative | calculation the number of patients with postpartum hemorrhage |
Countries
Egypt
Contacts
Primary Contacthany f sallam
Outcome results
None listed