A Randomized Trial of Induction Versus Expectant Management

Labor and Delivery Clinical Trial

— ARRIVE  

Official title:

Induction in Nulliparous Women at 39 Weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990612
• Other study ID #: HD36801-ARRIVE
• Secondary ID: UG1HD027869UG1HD
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• Source: The George Washington University Biostatistics Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.

Description:

Given the reported increased risks of adverse events in pregnancies extending beyond 39 weeks it has been hypothesized that a policy of planned elective induction at 39 weeks could improve outcomes for the infant and the mother. For multiparous patients, especially those with a favorable cervix, it is perhaps easy to justify an elective induction at 39 weeks given the low risk of cesarean section. However, for nulliparous patients the current evidence, derived mainly from retrospective observational studies, does not allow a clear recommendation. Nevertheless, a trend towards an increased rate of elective labor induction in pregnancies at 39 weeks has been reported, indicating that practitioners are more commonly using elective induction at this gestational age,even as others caution against routine elective induction prior to 41 weeks given the reported increased risk of cesarean delivery. Ultimately, a randomized controlled trial is necessary to satisfactorily understand whether elective induction of labor of nulliparas at 39 weeks improves neonatal and maternal outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6106
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Nulliparous - no previous pregnancy beyond 20 weeks

2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.

3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive based on clinical information and evaluation of the earliest ultrasound.

Exclusion Criteria:

1. Project gestational age at date of first ultrasound is > 20 weeks 6 days

2. Plan for induction of labor prior to 40 weeks 5 days

3. Plan for cesarean delivery or contraindication to labor

4. Breech presentation

5. Signs of labor (regular painful contractions with cervical change)

6. Fetal demise or known major fetal anomaly

7. Heparin or low-molecular weight heparin during the current pregnancy

8. Placenta previa, accreta, vasa previa

9. Active vaginal bleeding greater than bloody show

10. Ruptured membranes

11. Cerclage in current pregnancy

12. Known oligohydramnios, defined as AFI < 5 or MVP < 2

13. Fetal growth restriction, defined as EFW < 10th percentile

14. Known HIV positivity because of modified delivery plan

15. Major maternal medical illness associated with increased risk for adverse pregnancy outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac disease, renal insufficiency)

16. Refusal of blood products

17. Participation in another interventional study that influences management of labor at delivery or perinatal morbidity or mortality

18. Delivery planned elsewhere at a non-Network site

Related Conditions & MeSH terms

• Labor and Delivery

Intervention

Procedure:
• Elective Induction of Labor
Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University-Prentice Hospital	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University Hospital	Columbus	Ohio
United States	Dept of OB/GYN, Southwestern Medical Center, University of Texas	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	University of Texas - Galveston	Galveston	Texas
United States	University of Texas - Houston	Houston	Texas
United States	Columbia University-St. Luke's Hospital	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Magee Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Brown University	Providence	Rhode Island
United States	University of Utah	Salt Lake City	Utah
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
The George Washington University Biostatistics Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Sh — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Severe Neonatal Morbidity and Perinatal Mortality	Includes any one of: Perinatal death; Need for respiratory support within 72 hours after birth; Apgar score of 3 or less at 5 minutes; Hypoxic-ischemic encephalopathy; Seizure; Infection (confirmed sepsis or pneumonia); Meconium aspiration system; Birth trauma (bone fracture, neurologic injury or retinal hemorrhage); Intracranial or subaleal hemorrhage; Hypotension requiring vasopressor support	delivery through 72 hours after birth
Primary	Perinatal Death (Component of Primary Outcome)	Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death	antepartum pregnancy period through hospital discharge
Primary	Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)	Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation	Delivery through discharge
Primary	Number of Infants With Apgar Score =3 at 5 Minutes (Component of Primary Outcome)	The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.	Delivery through 5 minutes after birth
Primary	Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)		delivery through discharge
Primary	Number of Infants With Neonatal Seizure (Component of Primary Outcome)		Delivery through discharge
Primary	Number of Infants With Neonatal Infection (Component of Primary Outcome)	Neonatal infection includes confirmed sepsis and/or confirmed pneumonia	delivery through discharge
Primary	Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)		Delivery through discharge
Primary	Number of Infants With Birth Trauma (Component of Primary Outcome)	Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis	During the Delivery process
Primary	Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)	Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma	delivery through disharge
Primary	Hypotension Requiring Vasopressor Support (Component of Primary Outcome)		delivery through discharge
Secondary	Number of Participants With Cesarean Delivery		delivery
Secondary	Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery	Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas	delivery
Secondary	Participants Who Had Operative Vaginal Delivery		delivery
Secondary	Number of Participants Who Had Chorioamnionitis	Chorioamnionitis, defined as a clinical diagnosis before delivery	at any time from randomization through delivery
Secondary	Number of Participants With Third or Fourth Degree Perineal Laceration		delivery
Secondary	Number of Maternal Deaths	Maternal death at anytime between randomization and hospital discharge.	from randomization to hospital discharge
Secondary	Number of Participants Admitted to Intensive Care Unit (ICU)	Admission of the participant to the intensive care unit (ICU)	delivery through hospital discharge
Secondary	Number of Participants Experiencing Hypertensive Disorder of Pregnancy		Randomization to hospital discharge
Secondary	Number of Participants With Postpartum Hemorrhage	defined as any of the following: Transfusion; Non-elective hysterectomy; Use of two or more uterotonics other than oxytocin; Other surgical interventions such as uterine compression sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade; Curettage	delivery through hospital discharge
Secondary	Labor Agentry Scale Scores	Scores on the Labor Agentry Scale range from 29 to 203, with higher scores indicating greater perceived control during childbirth; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.	Between 6 hours after delivery and 8 weeks after delivery
Secondary	Labor Pain Scores	Labor pain was scored according to a 10-point Likert scale, with higher scores indicating greater pain; included are women who had spontaneous labor, labor that started spontaneously but then was augmented, or induced labor.	During labor and delivery
Secondary	Number of Participants With Maternal Postpartum Infection	Defined as any of the following: Clinical diagnosis of endometritis; Wound reopened for hematoma, seroma, infection or other reasons; Cellulitis requiring antibiotics; Pneumonia; Pyelonephritis; Bacteremia - unknown source; Septic pelvic thrombosis	delivery through discharge
Secondary	Number of Participants With Venous Thromboembolism	Maternal deep venous thrombosis or pulmonary embolism	delivery through discharge
Secondary	Number of Participants With Indications for Cesarean Delivery	Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication	Labor and delivery
Secondary	Duration of Respiratory Support	including ventilator, CPAP, high-flow nasal cannula (HFNC)	delivery through hospital discharge
Secondary	Number of Infants With Cephalohematoma		delivery through hospital discharge
Secondary	Shoulder Dystocia		delivery
Secondary	Number of Infants Who Had Transfusion of Blood Products or Blood		delivery through hospital discharge
Secondary	Number of Infants With Hyperbilirubinemia	Hyperbilirubinemia requiring phototherapy or exchange transfusion	delivery through discharge
Secondary	Number of Infants With Neonatal Hypoglycemia	glucose < 35 mg/dl and requiring IV therapy	delivery through discharge
Secondary	Number Infants Admitted to NICU or Intermediate Care	Number infants admitted to intensive care unit (NICU) or intermediate care unit	delivery through hospital discharge
Secondary	Number of Hours on the Labor and Delivery Unit	Median duration of stay in labor and delivery unit	Hours from admission to L&D to discharge from L&D
Secondary	Maternal Postpartum Length of Hospital Stay		delivery through hospital discharge
Secondary	Neonatal Length of Hospital Stay		delivery through hospital discharge
Secondary	Number of Participants With Indications for Operative Vaginal Delivery	Number of participants with indications for operative vaginal delivery including dystocia, non-reassuring fetal status and other indications	Labor and delivery
Secondary	Number of Participants and Breastfeeding Status at 4-8 Weeks After Delivery	Breastfeeding status includes breastfeeding, breastfeeding and formula feeding, or formula feeding	4-8 weeks after delivery