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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01501890
Other study ID # sor003411ctil
Secondary ID
Status Withdrawn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


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
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