Progesterone for First Trimester Vaginal Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Adi Weintraub, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01501890
First received: September 9, 2011
Last updated: December 29, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Threatened Abortion
Pre-Eclampsia
Abruptio Placentae
Fetal Growth Retardation
Premature Birth
Drug: dihydroxyprogesterone caproate
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Impact of Progesterone Treatment on Obstetrical Outcome Among Women With First Trimester Vaginal Bleeding

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • adverse pregnancy outcomes [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Uterine artery blood flow velocimetry [ Time Frame: One month after recruitment upon completion of treatment ] [ Designated as safety issue: No ]
    Systolic to diastolic ratio, pulsatility index, resistance index and peak systolic velocity

  • Placental pathological examination [ Time Frame: After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: No ]
    Placental weight and presence of infarcts, calcifications, fibrin deposits or signs of inflammation


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: dihydroxyprogesterone caproate
250mg once a week by intramuscular administration
Other Name: 17a-Hydroxyprogesterone caproate
Placebo Comparator: 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.
Drug: Placebo
0.9% NaCl
Other Name: Sailine, Physiological water

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

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501890

Contacts
Contact: Adi Y Weintraub, MD 972 547717053 adiyehud@bgu.ac.il

Locations
Israel
Soroka University Medical Center Not yet recruiting
Beer Sheva, Israel
Sub-Investigator: Adi Y Weintraub, MD         
Sub-Investigator: Reli Hershkovitz, MD         
Principal Investigator: Naama Buzaglo, MA         
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Ralika Hershkovitch, MD Soroka University Medical Center
  More Information

Publications:
Responsible Party: Adi Weintraub, Principal Investigator, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT01501890     History of Changes
Other Study ID Numbers: sor003411ctil
Study First Received: September 9, 2011
Last Updated: December 29, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Soroka University Medical Center:
Threatened Abortion
Progesterone
Subchorionic Hematoma
Pre-Eclampsia
Abruptio Placentae
Fetal Growth Retardation
Premature Birth

Additional relevant MeSH terms:
Eclampsia
Pre-Eclampsia
Premature Birth
Fetal Growth Retardation
Abruptio Placentae
Abortion, Threatened
Hypertension, Pregnancy-Induced
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Placenta Diseases
Abortion, Spontaneous
Progesterone
17-alpha-hydroxy-progesterone caproate
11-hydroxyprogesterone
Algestone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estradiol Antagonists
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on September 22, 2014