Abruptio Placentae, Fetal Growth Retardation, Pre-Eclampsia, Premature Birth, Threatened Abortion
Conditions
Keywords
Threatened Abortion, Progesterone, Subchorionic Hematoma, Pre-Eclampsia, Abruptio Placentae, Fetal Growth Retardation, Premature Birth
Brief summary
The purpose of this study is to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes.
Detailed description
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.
Interventions
DRUGdihydroxyprogesterone caproate
250mg once a week by intramuscular administration
DRUGPlacebo
0.9% NaCl
Sponsors
Soroka University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse pregnancy outcomes | 9 months | Miscarriage (also gestational age of miscarriage) Sonographic Intrauterine hematoma IUGR Placenta previa Pregnancy induced hypertension and preeclampsia/eclampsia Gestational age at delivery - Preterm delivery (before 37w); Early Preterm delivery (before 34w); and very early (before 28w) Mode of delivery Placental abruption PPROM Induction of labor PPH Apgar score Umbilical cord blood PH at birth Birth weight Fetal malformations Perinatal mortality Admission to the neonatal unit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine artery blood flow velocimetry | One month after recruitment upon completion of treatment | Systolic to diastolic ratio, pulsatility index, resistance index and peak systolic velocity |
| Placental pathological examination | After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days | Placental weight and presence of infarcts, calcifications, fibrin deposits or signs of inflammation |
Countries
Israel
Outcome results
None listed