An interventional study of dihydroxyprogesterone caproate and Placebo in Threatened Abortion, Pre-Eclampsia and Abruptio Placentae, sponsored by Soroka University Medical Center. Withdrawn at 1 site in Israel. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by Soroka University Medical Center · Not applicable, Interventional, and Prevention
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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.
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.
21 studies on the registry are indexed under Abortion, Threatened; 1 is open to participants now.
Browse Abortion, Threatened studies →Soroka University Medical Center is the lead sponsor of 160 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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: dihydroxyprogesterone caproate
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
250mg once a week by intramuscular administration
Also known as: 17a-Hydroxyprogesterone caproate
0.9% NaCl
Also known as: Sailine, Physiological water
adverse pregnancy outcomes
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
Time frame: 9 months
Uterine artery blood flow velocimetry
Systolic to diastolic ratio, pulsatility index, resistance index and peak systolic velocity
Time frame: One month after recruitment upon completion of treatment
Placental pathological examination
Placental weight and presence of infarcts, calcifications, fibrin deposits or signs of inflammation
Time frame: After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days
The record gives a start of Jan 2012, a primary completion of Dec 2013 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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