Timing of Delivery in Fetal Growth Restriction of Uncomplicated Women

NCT ID: NCT03046355

Last Updated: 2019-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-13
• Study Completion Date: 2019-03-18

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.

Conditions

Fetal Growth Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Labor induction at 37.0 to 37.6 weeks of gestation

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

Group Type: EXPERIMENTAL

Labor induction at 37.0 to 37.6 weeks of gestation

Intervention Type: PROCEDURE

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

Expectant monitoring until delivery

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Group Type: ACTIVE_COMPARATOR

Expectant monitoring until delivery

Intervention Type: PROCEDURE

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Interventions

Labor induction at 37.0 to 37.6 weeks of gestation

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

Intervention Type: PROCEDURE

Expectant monitoring until delivery

Diagnosis of FGR managed with expectant monitoring and delivery as indicated

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Chronic renal disease
• Antiphospholipid syndrome
• Hyperthyroidism
• Prior stillbirth
• Systemic lupus erythematous
• Hemoglobinopathies such as sickle cell disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Bahaeddine M Sibai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baha M Sibai, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Memorial Hermann Memorial City Medical Center

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Bellaire - Memorial Hermann

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-16-1053

Identifier Type: -

Identifier Source: org_study_id