Progesterone for First Trimester Vaginal Bleeding

NCT ID: NCT01501890

Last Updated: 2016-10-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-09-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

dihydroxyprogesterone caproate

Intervention Type: DRUG

250mg once a week by intramuscular administration

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% NaCl

Interventions

dihydroxyprogesterone caproate

250mg once a week by intramuscular administration

Intervention Type: DRUG

Placebo

0.9% NaCl

Intervention Type: DRUG

Other Intervention Names

17a-Hydroxyprogesterone caproate; Sailine, Physiological water

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Soroka University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Adi Weintraub

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralika Hershkovitch, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

Soroka University Medical Center

Beersheba, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 20410766 (View on PubMed)

Other Identifiers

sor003411ctil

Identifier Type: -

Identifier Source: org_study_id