Primary outcomeCount of participants· delivery through 72 hours after birth
Composite of Severe Neonatal Morbidity and Perinatal Mortality
| Group | Value (Participants) |
|---|---|
| Expectant Management | 164 |
| Elective Induction of Labor | 132 |
Trial · Interventional
CompletedNot applicableResults postedRegistry dataA Randomized Trial of Induction Versus Expectant Management
Short name ARRIVE
NCTNCT01990612 (opens ClinicalTrials.gov in a new tab)Other idHD36801-ARRIVEOther idUG1HD027869Other idUG1HD027915Other idUG1HD034116
This trial does not test a peptide that PepBank tracks.
- Measures Oxytocin, does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 6,106 participants (actual)
- Sponsor
- The George Washington University Biostatistics Center · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Mar 2014
- Primary completion
- Nov 2017
- Completion
- Jan 2018
- First posted
- 21 Nov 2013 (estimated)
- Last update posted
- 21 Feb 2019
- Conditions
- Labor and Delivery
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016201720182019
- N/A
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
A randomized clinical trial to assess whether elective induction of labor at 39 weeks of gestation compared with expectant management will improve outcomes.
Interventions
- Elective Induction of LaborProcedure
Arms2
No intervention
Expectant Management
Expectant management (unless a medical indication arises) until at least 40 weeks 5 days.
Other
Elective Induction of Labor
Elective induction of labor between 39 weeks 0 days and 39 weeks 4 days
Primary outcomes11
Outcomes the sponsor listed as primary.
Composite of Severe Neonatal Morbidity and Perinatal Mortality
Time frame · delivery through 72 hours after birth
Registry description
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
Perinatal Death (Component of Primary Outcome)
Time frame · antepartum pregnancy period through hospital discharge
Registry description
Perinatal death includes antepartum stillbirth, intrapartum stillbirth and neonatal death
Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)
Time frame · Delivery through discharge
Registry description
Respiratory support includes mechanical ventilation, continuous positive airway pressure or high flow nasal cannula and cardiorespiratory resuscitation
Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)
Time frame · Delivery through 5 minutes after birth
Registry description
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.
Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)
Time frame · delivery through discharge
Number of Infants With Neonatal Seizure (Component of Primary Outcome)
Time frame · Delivery through discharge
Number of Infants With Neonatal Infection (Component of Primary Outcome)
Time frame · delivery through discharge
Registry description
Neonatal infection includes confirmed sepsis and/or confirmed pneumonia
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)
Time frame · Delivery through discharge
Number of Infants With Birth Trauma (Component of Primary Outcome)
Time frame · During the Delivery process
Registry description
Birth trauma includes clavicular, skull or other fracture; brachial plexus palsy, facial nerve palsy, retinal hemorrhage or vocal cord paralysis
Number of Infants With Intracranial or Subgaleal Hemorrhage (Component of Primary Outcome)
Time frame · delivery through disharge
Registry description
Intracranial or subgaleal hemorrhage includes Intraventricular hemorrhage grades III or IV, subdural hematoma, subarachnoid hematoma, and subgaleal hematoma
Hypotension Requiring Vasopressor Support (Component of Primary Outcome)
Time frame · delivery through discharge
Secondary outcomes(20)
Number of Participants With Cesarean Delivery
Time frame · delivery
Number of Participants Who Had Uterine Incisional Extension at Cesarean Delivery
Time frame · delivery
Registry description
Incisional extensions at cesarean section, including J shape or T shape; or cervical traumas
Participants Who Had Operative Vaginal Delivery
Time frame · delivery
Number of Participants Who Had Chorioamnionitis
Time frame · at any time from randomization through delivery
Registry description
Chorioamnionitis, defined as a clinical diagnosis before delivery
Number of Participants With Third or Fourth Degree Perineal Laceration
Time frame · delivery
Number of Maternal Deaths
Time frame · from randomization to hospital discharge
Registry description
Maternal death at anytime between randomization and hospital discharge.
Number of Participants Admitted to Intensive Care Unit (ICU)
Time frame · delivery through hospital discharge
Registry description
Admission of the participant to the intensive care unit (ICU)
Number of Participants Experiencing Hypertensive Disorder of Pregnancy
Time frame · Randomization to hospital discharge
Number of Participants With Postpartum Hemorrhage
Time frame · delivery through hospital discharge
Registry description
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
Labor Agentry Scale Scores
Time frame · Between 6 hours after delivery and 8 weeks after delivery
Registry description
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.
Labor Pain Scores
Time frame · During labor and delivery
Registry description
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.
Number of Participants With Maternal Postpartum Infection
Time frame · delivery through discharge
Registry description
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
Number of Participants With Venous Thromboembolism
Time frame · delivery through discharge
Registry description
Maternal deep venous thrombosis or pulmonary embolism
Number of Participants With Indications for Cesarean Delivery
Time frame · Labor and delivery
Registry description
Number of participants with indications for cesarean delivery including dystocia, non-reassuring fetal status or other indication
Duration of Respiratory Support
Time frame · delivery through hospital discharge
Registry description
including ventilator, CPAP, high-flow nasal cannula (HFNC)
Number of Infants With Cephalohematoma
Time frame · delivery through hospital discharge
Shoulder Dystocia
Time frame · delivery
Number of Infants Who Had Transfusion of Blood Products or Blood
Time frame · delivery through hospital discharge
Number of Infants With Hyperbilirubinemia
Time frame · delivery through discharge
Registry description
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Number of Infants With Neonatal Hypoglycemia
Time frame · delivery through discharge
Registry description
glucose \< 35 mg/dl and requiring IV therapy
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeCount of participants· antepartum pregnancy period through hospital discharge
Perinatal Death (Component of Primary Outcome)
| Group | Value (Participants) |
|---|---|
| Expectant Management | 3 |
| Elective Induction of Labor | 2 |
Primary outcomeCount of participants· Delivery through discharge
Number of Participant Infants Requiring Respiratory Support (Component of Primary Outcome)
| Group | Value (Participants) |
|---|---|
| Expectant Management | 127 |
| Elective Induction of Labor | 91 |
Primary outcomeCount of participants· Delivery through 5 minutes after birth
Number of Infants With Apgar Score ≤3 at 5 Minutes (Component of Primary Outcome)
| Group | Value (Participants) |
|---|---|
| Expectant Management | 18 |
| Elective Induction of Labor | 12 |
Primary outcomeCount of participants· delivery through discharge
Number of Infants With Neonatal Hypoxic-ischemic Encelphalopathy (Component of Primary Outcome)
| Group | Value (Participants) |
|---|---|
| Expectant Management | 20 |
| Elective Induction of Labor | 14 |
Primary outcomeCount of participants· Delivery through discharge
Number of Infants With Neonatal Seizure (Component of Primary Outcome)
| Group | Value (Participants) |
|---|---|
| Expectant Management | 4 |
| Elective Induction of Labor | 11 |
Primary outcomeCount of participants· delivery through discharge
Number of Infants With Neonatal Infection (Component of Primary Outcome)
| Group | Value (Participants) |
|---|---|
| Expectant Management | 12 |
| Elective Induction of Labor | 9 |
Primary outcomeCount of participants· Delivery through discharge
Number of Infants With Meconium Aspiration Syndrome (Component of Primary Outcome)
| Group | Value (Participants) |
|---|---|
| Expectant Management | 26 |
| Elective Induction of Labor | 17 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Expectant ManagementExpectant management (unless a medical indication arises) until at least 40 weeks 5 days. | 3 / 3059 | 3 / 3037 | 0 / 3037 |
| Elective Induction of LaborElective induction of labor between 39 weeks 0 days and 39 weeks 4 days 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. | 2 / 3037 | 2 / 3059 | 0 / 3059 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultGrobman 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 Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566. PMID 30089070
- DerivedMallett G, Hill K, Doherty L, Grobman WA, Reddy UM, Tita ATN, Silver RM, Rice MM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Costantine MM, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN, Macones GA; The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Maternal and Delivery Characteristics and Self-Reported Perceived Control During Labor. Obstet Gynecol. 2023 Jul 1;142(1):117-124. doi: 10.1097/AOG.0000000000005230. PMID 37290106
- DerivedCostantine MM, Sandoval GJ, Grobman WA, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units (MFMU) Network. Association of Body Mass Index With the Use of Health Care Resources in Low-Risk Nulliparous Pregnancies After 39 Weeks of Gestation. Obstet Gynecol. 2022 May 1;139(5):866-876. doi: 10.1097/AOG.0000000000004753. Epub 2022 Apr 5. PMID 35576345
- DerivedSilver RM, Rice MM, Grobman WA, Reddy UM, Tita ATN, Mallett G, Hill K, Thom EA, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation. Obstet Gynecol. 2020 Oct;136(4):698-705. doi: 10.1097/AOG.0000000000004046. PMID 32925634
- DerivedMallett G, Hill K, de Voest J, Bousleiman SZ, Allard D, Harris S, Salazar A, Clark K, Ortiz F, Bartholomew A, Dalton W, Craig J, Bickus M; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy. Obstet Gynecol. 2020 Oct;136(4):731-737. doi: 10.1097/AOG.0000000000003998. PMID 32925629
- DerivedEl-Sayed YY, Rice MM, Grobman WA, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*. Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women. Obstet Gynecol. 2020 Oct;136(4):692-697. doi: 10.1097/AOG.0000000000004055. PMID 32925628
- DerivedDude A, Fette LM, Reddy UM, Tita ATN, Silver RM, El-Sayed YY, Wapner RJ, Rouse DJ, Saade GR, Thorp JM Jr, Chauhan SP, Iams JD, Chien EK, Casey BM, Srinivas SK, Swamy GK, Simhan HN; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Maternal Sense of Control During Childbirth and Infant Feeding Method. Obstet Gynecol. 2020 Mar;135(3):583-590. doi: 10.1097/AOG.0000000000003697. PMID 32028504
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- Not stated
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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