Progesterone for First Trimester Vaginal Bleeding

Premature Birth Clinical Trial

Official title:

The Impact of Progesterone Treatment on Obstetrical Outcome Among Women With First Trimester Vaginal Bleeding

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01501890
• Other study ID #: sor003411ctil
• Status: Withdrawn
• Phase: N/A
• First received: September 9, 2011
• Last updated: October 24, 2016
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2016
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abortion, Threatened
• Abruptio Placentae
• Eclampsia
• Fetal Growth Retardation
• Pre-Eclampsia
• Premature Birth
• Threatened Abortion
• Uterine Hemorrhage

Intervention

Drug:
• dihydroxyprogesterone caproate
250mg once a week by intramuscular administration
• Placebo
0.9% NaCl

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Lykke JA, Dideriksen KL, Lidegaard O, Langhoff-Roos J. First-trimester vaginal bleeding and complications later in pregnancy. Obstet Gynecol. 2010 May;115(5):935-44. doi: 10.1097/AOG.0b013e3181da8d38. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	9 months	No
Secondary	Uterine artery blood flow velocimetry	Systolic to diastolic ratio, pulsatility index, resistance index and peak systolic velocity	One month after recruitment upon completion of treatment	No
Secondary	Placental pathological examination	Placental weight and presence of infarcts, calcifications, fibrin deposits or signs of inflammation	After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days	No