Elective Induction of Nulliparous Labor

NCT01076062 | Completed DMC

• 1 other identifier: 210013
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Primary outcome: to evaluate the effect of elective induction of labor (IOL), at 39 weeks gestation, on cesarean delivery rates in nulliparous women compared to expectant management (EM). Secondary outcomes: to evaluate differences in the mean number of clinic visits/antepartum tests avoided with IOL, to compare the differences in utilization of inpatient resources (mean duration of inpatient stay, mean duration of labor), and to evaluate the effect of IOL on the risk of urinary/anal incontinence and sexual dysfunction as analyzed using previously validated measurements. We will evaluate differences in the rate of cervical change once active labor is diagnosed, and the time from completion of active labor, defined as complete dilation and complete effacement, to the delivery of fetus (definition of second stage of active labor). Furthermore, other secondary outcomes to be evaluated include comparisons between IOL and EM in regards to the occurence of chorioamnionitis, stillbirth, operative vaginal delivery, and meconium stained amniotic fluid. An evaluation of the predictive value of cervical length and Bishop score for vaginal delivery will also be examined.

Conditions

Pregnancy

Keywords

Pregnancy Maintenance; Labor, Induced; spontaneous labor; cesarean delivery

Outcome Measures

Primary Outcomes (1)

• Cesarean Birth Rate

  39 weeks gestation

Study Arms (2)

Expectant management (EM) arm

NO INTERVENTION

Standard of care: routine clinic appointments until they deliver, fetal heart rate and contraction monitoring during their 41st week if not delivered. Also if they have not gone into labor the subjects will be scheduled for an induction by 42 weeks.

Induction of Labor (IOL) arm

EXPERIMENTAL

Elective induction of labor at 39 weeks.

Procedure: Induction of Labor

Interventions

Induction of Labor PROCEDURE

If cervical foley bulb placement is possible, the foley bulb will remain in place until either spontaneously removed or after 12 hrs, whichever is earlier. If placement is not possible, cervical ripening with misoprostol 25 micrograms (mcg) per vagina every 4 hrs (max of 4 total doses) will be initiated. Cervical examination will occur every 4 hr. Repeat doses of misoprostol will be given only if foley bulb placement is not possible and/or if palpably firm uterine contractions are less than 6 in 10 min in consecutive 10 min intervals. Once placement of a cervical foley bulb can be performed, oxytocin administration will begin at 2 mIU/min and increasing by 2 mIU/min every 20 min to ensure adequate contractions (maximum oxytocin infusion rate 36 mIU/min). Adequate contractions will be defined as 7 contractions in 15 min in consecutive 15 min intervals that palpate moderate to firm. Oxytocin infusion will begin not earlier than 4 hrs after the last misoprostol dose (if given).

Also known as: misoprostol, oxytocin

Induction of Labor (IOL) arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous patients evaluated at 38 weeks gestation without contraindication for induction of labor, and
• Patients who meet dating criteria as outlined above, and
• Patients who have a Bishop score of ≤ 5.

You may not qualify if:

• Contraindication to induction of labor,
• Scheduled induction of labor for medical indications, and/or
• Failure to meet dating criteria above, Bishop score of \> 5.

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (3)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

• Middleton P, Shepherd E, Morris J, Crowther CA, Gomersall JC. Induction of labour at or beyond 37 weeks' gestation. Cochrane Database Syst Rev. 2020 Jul 15;7(7):CD004945. doi: 10.1002/14651858.CD004945.pub5.

  PMID: 32666584 DERIVED

• Miller NR, Cypher RL, Foglia LM, Pates JA, Nielsen PE. Elective Induction of Labor Compared With Expectant Management of Nulliparous Women at 39 Weeks of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2015 Dec;126(6):1258-1264. doi: 10.1097/AOG.0000000000001154.

  PMID: 26551184 DERIVED

MeSH Terms

Interventions

Labor, Induced; Misoprostol; Oxytocin

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nathaniel R Miller, MD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Nielsen, MD

  Madigan Army Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 25, 2010
• Study Start: October 27, 2009
• Primary Completion: April 24, 2017
• Study Completion: April 24, 2017
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (1)