Placenta Previa
Conditions
Keywords
cesarean section, placenta previa, antepartum hemorrhage, vaginal progesterone, 17-Alpha-Hydroxyprogesterone Caproate
Brief summary
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
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.
Interventions
DRUG17-OHPC
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.
DRUGvaginal progesterone
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
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
An open-label randomized controlled study
Intervention model description
A randomized controlled study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of patient delivered before 37 weeks | 2 month | calculation the number of patients delivered before 37 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of episodes of antepartum hemorrhage | 2 month | calculating the mean number of episodes of antepartum hemorrhage |
| Hospital admission for significant antepartum hemorrhage | 2 month | Number of patients requiring hospital admission for significant antepartum hemorrhage |
| Neonatal Birth weight | one hours post operative | measure Neonatal Birth weight in kilograms |
Countries
Egypt
Contacts
Primary Contacthany f sallam, md
Outcome results
None listed