Progesterone for First Trimester Vaginal Bleeding
Palabras clave
Abstracto
Descripción
First trimester vaginal bleeding is one of the most common pregnancy complications affecting 15-25% of all pregnancies. Threatened abortion is defined as bleeding through a closed cervical os in the first half of pregnancy. A subchorionic hematoma (SCH) is found in 18-39% of women with a threatened miscarriage and around 70% of women with a SCH will experience vaginal bleeding. Data on the relationship between first trimester vaginal bleeding and obstetric outcome is described mainly in retrospective and noncontrolled studies. It is hypothesized that first trimester bleeding is an indicator of a general tendency for complications (such as: preterm premature rupture of membranes (PPROM), preterm delivery (< 37 weeks gestation; PTD) low birth weight (<1500g; LBW) neonates, small for gestational age (SGA) neonates, placenta previa, placental abruption and stillbirth) later on in pregnancy.
Nowadays, there are not scientific based treatments for the prevention of complications associated with SCH and vaginal bleeding. Nevertheless, recent data have suggested that prophylactic administration of progesterone leads to a significant reduction in the rate of preterm deliveries and SGA neonates among patients with PTD or SGA neonates in the past. Although progesterone administration for threatened miscarriage was not studied, many physicians treat patients with first trimester vaginal bleeding with progesterone. In this era of evidence based medicine, the researchers aim to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes. The researchers hypothesize that treatment with progesterone for first trimester vaginal bleeding will alter the rates of the above mentioned obstetrical complications and adverse pregnancy outcomes.
fechas
| Verificado por última vez: | 09/30/2016 |
| Primero enviado: | 09/08/2011 |
| Inscripción estimada enviada: | 12/26/2011 |
| Publicado por primera vez: | 12/29/2011 |
| Última actualización enviada: | 10/23/2016 |
| Última actualización publicada: | 10/25/2016 |
| Fecha de inicio real del estudio: | 12/31/2011 |
| Fecha estimada de finalización primaria: | 11/30/2013 |
| Fecha estimada de finalización del estudio: | 08/31/2014 |
Condición o enfermedad
Intervención / tratamiento
Drug: Progesterone
Drug: Placebo
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Progesterone Women attending the Gynecological Emergency Unit due to first trimester vaginal bleeding, with a viable singleton pregnancy at a gestational age of 6-13 completed weeks of gestation | Drug: Progesterone 250mg once a week by intramuscular administration |
| Placebo Comparator: Placebo Women attending the Gynecological Emergency Unit due to first trimester vaginal bleeding, with a viable singleton pregnancy at a gestational age of 6-13 completed weeks of gestation. | Drug: Placebo 0.9% NaCl |
Criterio de elegibilidad
| Edades elegibles para estudiar | 16 Years A 16 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Low risk pregnancies - Intrauterine pregnancy documented sonographically - Singleton pregnancy - Known gestational age - Healthy women Exclusion Criteria: - Women after reproductive assistant techniques - Women treated with progesterone - Multiple pregnancies |
Salir
Medidas de resultado primarias
1. adverse pregnancy outcomes [9 months]
Medidas de resultado secundarias
1. Uterine artery blood flow velocimetry [One month after recruitment upon completion of treatment]
2. Placental pathological examination [After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days]
