17-Alpha-Hydroxyprogesterone Caproate in Pregnant Women With Placenta Previa
Raktažodžiai
Santrauka
apibūdinimas
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.
Datos
| Paskutinį kartą patikrinta: | 01/31/2019 |
| Pirmasis pateikimas: | 12/14/2018 |
| Numatytas registravimas pateiktas: | 12/14/2018 |
| Pirmas paskelbtas: | 12/18/2018 |
| Paskutinis atnaujinimas pateiktas: | 02/13/2019 |
| Paskutinis atnaujinimas paskelbtas: | 02/14/2019 |
| Faktinė studijų pradžios data: | 12/31/2018 |
| Numatoma pirminio užbaigimo data: | 12/30/2021 |
| Numatoma studijų užbaigimo data: | 02/28/2022 |
Būklė ar liga
Intervencija / gydymas
Drug: 17-OHPC
Drug: placebo to 17-OHPC
Fazė
Rankų grupės
| Ranka | Intervencija / gydymas |
|---|---|
| Active Comparator: 17-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 | Drug: 17-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 |
| Placebo Comparator: placebo to 17-OHPC 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 patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery |
Tinkamumo kriterijai
| Amžius, tinkami studijuoti | 18 Years Į 18 Years |
| Tinkamos studijoms lytys | Female |
| Priima sveikus savanorius | Taip |
| Kriterijai | 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 |
Rezultatas
Pirminės rezultatų priemonės
1. the duration of prolongation of pregnancy from the time of enrollment to the time of delivery [6 weeks]
Antrinės rezultatų priemonės
1. apgar score [5 minutes postpartum]
2. the number of patients with postpartum hemorrhage [24 hours post operative]
