Vaginal Progesterone Versus 17-Alpha-Hydroxyprogesterone Caproate in Placenta Previa
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 01/31/2019 |
| Primero enviado: | 12/14/2018 |
| Inscripción estimada enviada: | 12/14/2018 |
| Publicado por primera vez: | 12/18/2018 |
| Última actualización enviada: | 02/13/2019 |
| Última actualización publicada: | 02/14/2019 |
| Fecha de inicio real del estudio: | 12/31/2018 |
| Fecha estimada de finalización primaria: | 12/30/2021 |
| Fecha estimada de finalización del estudio: | 03/31/2022 |
Condición o enfermedad
Intervención / tratamiento
Drug: 17-OHPC
Drug: vaginal progesterone
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: 17-OHPC 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 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. |
| Active Comparator: vaginal progesterone 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 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 |
| No Intervention: control group Women with gestational age from 26-28 weeks diagnosed with placenta previa who will not receive vaginal progesterone. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | 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. |
Salir
Medidas de resultado primarias
1. number of patient delivered before 37 weeks [2 month]
Medidas de resultado secundarias
1. number of episodes of antepartum hemorrhage [2 month]
2. Hospital admission for significant antepartum hemorrhage [2 month]
3. Neonatal Birth weight [one hours post operative]
