Progesterone in Patients With Placenta Previa
Palabras clave
Abstracto
Descripción
Eligible women who consent to participate in the study are randomly allocated into one of the two study groups. Women who are allocated to the study group will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer); while the other group will serve as controls. Patients will be followed up till delivery for the incidence in antepartum hemorrhagic episodes.
fechas
| Verificado por última vez: | 07/31/2018 |
| Primero enviado: | 06/29/2016 |
| Inscripción estimada enviada: | 08/14/2018 |
| Publicado por primera vez: | 08/15/2018 |
| Última actualización enviada: | 08/14/2018 |
| Última actualización publicada: | 08/15/2018 |
| Fecha de inicio real del estudio: | 07/04/2018 |
| Fecha estimada de finalización primaria: | 06/30/2019 |
| Fecha estimada de finalización del estudio: | 07/31/2019 |
Condición o enfermedad
Intervención / tratamiento
Drug: Vaginal progesterone group
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Vaginal progesterone group Women will receive vaginal progesterone 400 mg [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt], once at bed time starting from 26-28 weeks of gestation and till 36 weeks of gestation or delivery (which is closer). | Drug: Vaginal progesterone group 400 mg vaginal progesterone [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer). |
| 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: 1. Gestational age 26-28 weeks of gestation. 2. Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using a transvaginal ultrasound scan. Exclusion Criteria: 1. Multiple pregnancy. 2. Women at high risk of preterm labor e.g. history of spontaneous preterm labor or preterm prelabor rupture of the membranes (PPROM). 3. Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery. 4. Women who have been maintained on progestin therapy since early pregnancy for whatever reason. |
Salir
Medidas de resultado primarias
1. Incidence of preterm delivery due to severe antepartum hemorrhage. [from 26 weeks till 37 weeks]
Medidas de resultado secundarias
1. No. of episodes of antepartum hemorrhage. [from 26 weeks till 37 weeks]
2. Hospital admission for significant antepartum hemorrhage. [from 26 weeks till 37 weeks]
3. Hospital admission for threatened preterm labor. [from 26 weeks till 37 weeks]
4. Need for blood transfusion. [from 26 weeks till 37 weeks]
5. Incidence of severe postpartum hemorrhage. [from 26 weeks till 37 weeks]
6. Incidence of Cesarean hysterectomy. [from 26 weeks till 37 weeks]
7. Patient compliance [from 26 weeks till 37 weeks]
8. Patient satisfaction: Likert Scale [from 26 weeks till 37 weeks]
9. Neonatal Birth weight. [At birth]
10. Need for NICU admission and its duration. [At birth]
11. Respiratory morbidity (transient tachypnea or respiratory distress syndrome). [At birth]
12. Prematurity-related mortality. [28 days postpartum]
