NCT01501890

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.9 years

First QC Date

September 9, 2011

Last Update Submit

October 24, 2016

Conditions

Threatened AbortionPre-EclampsiaAbruptio PlacentaeFetal Growth RetardationPremature Birth

Keywords

Threatened AbortionProgesteroneSubchorionic HematomaPre-EclampsiaAbruptio PlacentaeFetal Growth RetardationPremature Birth

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Uterine artery blood flow velocimetry

    One month after recruitment upon completion of treatment

  • Placental pathological examination

    After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days

Study Arms (2)

Progesterone

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

dihydroxyprogesterone caproateDRUG

250mg once a week by intramuscular administration

Also known as: 17a-Hydroxyprogesterone caproate
Progesterone
PlaceboDRUG

0.9% NaCl

Also known as: Sailine, Physiological water
Placebo

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Low risk pregnancies
  • Intrauterine pregnancy documented sonographically
  • Singleton pregnancy
  • Known gestational age
  • Healthy women

You may not qualify if:

  • Women after reproductive assistant techniques
  • Women treated with progesterone
  • Multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

Location

Related 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):935-944. doi: 10.1097/AOG.0b013e3181da8d38.

    PMID: 20410766BACKGROUND

MeSH Terms

Conditions

Abortion, ThreatenedPre-EclampsiaAbruptio PlacentaeFetal Growth RetardationPremature Birth

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertension, Pregnancy-InducedObstetric Labor ComplicationsPlacenta DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsObstetric Labor, Premature

Study Officials

  • Ralika Hershkovitch, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 9, 2011

First Posted

December 30, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

September 1, 2014

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

IL(1)