Clinical trial NCT01501890: Progesterone for First Trimester Vaginal Bleeding
Official title: The Impact of Progesterone Treatment on Obstetrical Outcome Among Women With First Trimester Vaginal Bleeding
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Threatened Abortion
Pre-Eclampsia
Abruptio Placentae
Fetal Growth Retardation
Premature Birth
Keywords: Threatened Abortion
Progesterone
Subchorionic Hematoma
Pre-Eclampsia
Abruptio Placentae
Fetal Growth Retardation
Premature Birth
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: adverse pregnancy outcomes
timeFrame: 9 months
Secondary outcomes:
measure: Uterine artery blood flow velocimetry
timeFrame: One month after recruitment upon completion of treatment
measure: Placental pathological examination
timeFrame: After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Ralika Hershkovitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lykke JA, Dideriksen KL, Lidegaard O, Langhoff-Roos J. First-trimester vaginal bleeding and complications later in pregnancy. Obstet Gynecol. 2010 May;115(5):935-944. doi: 10.1097/AOG.0b013e3181da8d38.