NCT03046355

Brief Summary

The goal of the study is to determine whether labor induction at 37 weeks of pregnancy can improve the baby's health at birth when compared with delivery at a later point in the pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

February 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

March 13, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2019

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

February 6, 2017

Last Update Submit

June 11, 2019

Conditions

Fetal Growth Restriction

Outcome Measures

Primary Outcomes (1)

  • Number of children with birthweight less than the third percentile for gestational as assessed by NICHD nomograms

    NICHD is National Institute of Child Health and Human Development The NICHD nomogram will indicate their birth weight percentile based on their gestational age and ethnicity

    Immediately at birth

Secondary Outcomes (5)

  • Number of children presenting with CNM

    Up to 6 weeks after delivery

  • Number of women presenting with CMM

    Up to 6 weeks after delivery

  • Number of children delivered by cesarean section

    Immediately at birth

  • Number of children admitted to NICU

    Up to 6 weeks after delivery

  • Number of children presenting with SGA

    Immediately at birth

Study Arms (2)

Labor induction at 37.0 to 37.6 weeks of gestation

EXPERIMENTAL

Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days

Procedure: Labor induction at 37.0 to 37.6 weeks of gestation

Expectant monitoring until delivery

ACTIVE COMPARATOR

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Procedure: Expectant monitoring until delivery

Interventions

Labor induction at 37.0 to 37.6 weeks of gestationPROCEDURE

Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days

Labor induction at 37.0 to 37.6 weeks of gestation
Expectant monitoring until deliveryPROCEDURE

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Expectant monitoring until delivery

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Singleton pregnancy
  • Gestational age 34 weeks 0 days to 37 weeks 0 days at time of enrollment
  • Dating of pregnancy by last menstrual period consistent with an ultrasound, ultrasound \<21 weeks and 6 days of gestation, or known date of conception in the setting of in vitro fertilization
  • No known major anomalies (anomalies requiring surgery antenatally or in the neonatal period, anomalies not compatible with life as determined by the physician)
  • FGR defined as estimated fetal weight (EFW) \< 10th percentile by Hadlock formula with normal umbilical artery Doppler studies and normal amniotic fluid

You may not qualify if:

  • Known major fetal anomalies
  • Multiple gestation or selective reduction of multiple gestation after 14 weeks
  • Previous stillbirth at term
  • Indications for delivery at \<39 weeks. Common examples include:
  • Placenta previa
  • Placenta accreta
  • Vasa previa
  • History of classical cesarean section or myomectomy
  • Human immunodeficiency virus (HIV)
  • Oligohydramnios (low amniotic fluid, defined as maximum vertical pocket \<2.0cm)
  • High-risk pregnancy as determined by the physician. Common examples include:
  • Pre-gestational diabetes or gestational diabetes on medication
  • Chronic hypertension on medication
  • Maternal cardiac disease
  • Asthma requiring oral steroids during pregnancy
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Memorial Hermann Memorial City Medical Center

Houston, Texas, 77024, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Bellaire - Memorial Hermann

Houston, Texas, 77401, United States

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Baha M Sibai, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 8, 2017

Study Start

March 13, 2017

Primary Completion

March 18, 2019

Study Completion

March 18, 2019

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations

US(3)