Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03218735
Other study ID # HSC-MS-17-0110
Secondary ID
Status Withdrawn
Phase N/A
First received July 12, 2017
Last updated December 21, 2017
Start date July 12, 2017
Est. completion date August 1, 2019

Study information

Verified date December 2017
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the incidence of composite neonatal morbidity and birthweight >4500 grams among uncomplicated large for gestational age (LGA) fetal growth at delivered 37 weeks versus expectant management.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 39 Years
Eligibility Inclusion Criteria:

- Singleton pregnancy

- Plan for vaginal delivery. Patients with prior cesarean section are eligible if they are planning for a trial of labor after cesarean section.

- 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)

- LGA defined as estimated fetal weight (EFW) > 90th percentile by Hadlock formula but <4500 grams

Exclusion Criteria:

- Pre-gestational diabetes or gestational diabetes on medication (oral or insulin, excluding metformin)

- Planned cesarean delivery

- Polyhydramnios

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Labor induction at 37.0 weeks to 37.6 weeks of gestation
Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
Expectant monitoring and delivery
Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Harris Health System, Lyndon B Johnson Hospital obstetrics and gynecology clinic

Outcome

Type Measure Description Time frame Safety issue
Primary Number of children presenting with CNM Composite neonatal morbidity (CNM) is any of the following: Apgar score <5 at 5 minutes, seizure, fracture of skull, humerus, or clavicle, neonatal brachial plexus palsy, facial nerve palsy, oxygen supplementation >4 hours, CPAP >2 hours, mechanical ventilation, or death before discharge or IUFD. Up to 6 weeks after delivery
Primary Number of children with birthweight above 4500 grams Immediately at birth
Secondary Number of women presenting with CMM Composite maternal morbidity (CMM) is any of the following: chorioamnionitis, shoulder dystocia, 3rd or 4th degree laceration or episiotomy, transfusion of blood products, endometritis, wound infection or separation, deep venous thrombosis, pulmonary embolism, admission to the intensive care unit, or death. Rates of cesarean section as well as indications in each group will also be evaluated. Up to 6 weeks after delivery
Secondary Number of children delivered by cesarean section Immediately at birth
Secondary Number of children admitted to NICU NICU is neo-natal intensive care unit Up to 6 weeks after delivery
See also
  Status Clinical Trial Phase
Terminated NCT00141895 - A Randomized Trial of Two Regimens of Misoprostol for Second Trimester Termination for Intrauterine Fetal Death Phase 3
Completed NCT03039036 - Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction N/A
Completed NCT05827731 - Cervical Double Balloon Combined With Oxytocin N/A
Recruiting NCT04035382 - BMI-Associated Labor Induction: A Prospective Trial N/A
Withdrawn NCT00771511 - Cervical Capsaicin for Labor Induction and Pain Relief Phase 4
Recruiting NCT04075630 - Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction
Active, not recruiting NCT04573517 - Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor N/A
Withdrawn NCT05257187 - Foley Catheter Induction N/A
Recruiting NCT03016442 - Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening Phase 2
Not yet recruiting NCT00984347 - Breast Stimulation Versus Pitocin for Induction of Labor N/A
Completed NCT04596397 - Oral Misoprostol for Outpatient Induction of Labor N/A
Completed NCT03504670 - Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial N/A
Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT01402050 - Foley Catheter Versus Cervidil for Induction of Labor at Term N/A
Completed NCT00529295 - Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term Phase 3
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A
Completed NCT00346840 - Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour Phase 2
Completed NCT02639429 - Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial Phase 4