Breast Stimulation vs. Low Dose Oxytocin Augmentation for Labor Induction

NCT05510310 | Unknown Phase 1 FDA Drug FDA Device

• 1 other identifier: 0101-21-NHR
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To find the preferred method of labor induction (birth augmentation) for women with a history of one prior cesarean section scar and in grandmultiparas, the difference in time interval from augmentation to delivery will be measured between breast stimulation vs. low-dose oxytocin administration in this prospective single-center randomized controlled trial.

Conditions

Labor Onset and Length Abnormalities; Uterine Rupture; Birth; Induced

Keywords

labor induction; birth augmentation; uterine scarring; caesarian section

Outcome Measures

Primary Outcomes (1)

• Time interval from augmentation of labor to delivery

  up to 48 hours

Secondary Outcomes (5)

• Montevideo units in each group

  active first and second stage of labor (up to 48 hours)

• rate of women who achieved vaginal delivery

  during labor (48 hours)

• Endometritis

  during one week postpartum

• Postpartum hemorrhage

  during the first 24 hours after labor

• Apgar score 3 or less at 5 minutes

  during the first 5 minutes postpartum

Study Arms (2)

Breast stimulation

EXPERIMENTAL

Breast pump for breast stimulation: The suction cup will be placed on the breast, held by the patient or a strap, alternated between nipples every 15 minutes, with a pause of 15 minutes after each 30 minutes. Suction intensity will be adjusted to the maximum tolerated by the patient while avoiding causing pain or discomfort. Treatment will be continued for a maximum of 12 hours.

Procedure: Breast stimulation

Low-dose oxytocin

ACTIVE COMPARATOR

Low-dose oxytocin will be administered intravenously, starting at a dose of 0.5-2 milliunits\\minute, and increasing incrementally by 1-2 milliunites\\minute every 15-40 minutes. Treatment will be continued for a maximum of 12 hours.

Biological: Oxytocin

Interventions

Breast stimulation PROCEDURE

By breast pump

Breast stimulation

Oxytocin BIOLOGICAL

Oxytocin will be administered intravenously and titrated

Low-dose oxytocin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton vertex gestations at or beyond 37 weeks of gestation
• History of one prior cesarean section scar or grandmultipara (birth number 6 and above),
• Spontaneous onset of labor or after labor induction by Foley balloon catheter, eligible for this trial
• Determined by the obstetrics care team that augmentation was needed.
• Augmentation will be initiated at or beyond 2.5 cm dilation, with or without ruptured membranes and uterine activity less than 3 contractions in 10 minutes on tocodynamometry.

You may not qualify if:

• History of two prior cesarean section scars,
• Younger than 18 years,
• Any contraindication for vaginal birth (placenta previa, vasa previa, cord presentation, inadequate pelvis, prior uterine rupture),
• Fetuses in nonvertex presentation
• Fetuses with suspected life-limiting anomalies,
• Suspected abruption or bleeding of unknown origin,
• Women who did not agree to the enter the study.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galil Medical Center

Nahariya, Israel

Location

Related Publications (15)

• Sentilhes L, Vayssiere C, Beucher G, Deneux-Tharaux C, Deruelle P, Diemunsch P, Gallot D, Haumonte JB, Heimann S, Kayem G, Lopez E, Parant O, Schmitz T, Sellier Y, Rozenberg P, d'Ercole C. Delivery for women with a previous cesarean: guidelines for clinical practice from the French College of Gynecologists and Obstetricians (CNGOF). Eur J Obstet Gynecol Reprod Biol. 2013 Sep;170(1):25-32. doi: 10.1016/j.ejogrb.2013.05.015. Epub 2013 Jun 28.

  PMID: 23810846 BACKGROUND

• Beucher G, Dolley P, Levy-Thissier S, Florian A, Dreyfus M. [Maternal benefits and risks of trial of labor versus elective repeat caesarean delivery in women with a previous caesarean delivery]. J Gynecol Obstet Biol Reprod (Paris). 2012 Dec;41(8):708-26. doi: 10.1016/j.jgyn.2012.09.028. Epub 2012 Nov 14. French.

  PMID: 23159201 BACKGROUND

• Penfield CA, Wing DA. Labor Induction Techniques: Which Is the Best? Obstet Gynecol Clin North Am. 2017 Dec;44(4):567-582. doi: 10.1016/j.ogc.2017.08.011.

  PMID: 29078939 BACKGROUND

• Deruelle P, Lepage J, Depret S, Clouqueur E. [Induction of labor and intrapartum management for women with uterine scar]. J Gynecol Obstet Biol Reprod (Paris). 2012 Dec;41(8):788-802. doi: 10.1016/j.jgyn.2012.09.030. Epub 2012 Nov 9. French.

  PMID: 23142358 BACKGROUND

• Christensson K, Nilsson BA, Stock S, Matthiesen AS, Uvnas-Moberg K. Effect of nipple stimulation on uterine activity and on plasma levels of oxytocin in full term, healthy, pregnant women. Acta Obstet Gynecol Scand. 1989;68(3):205-10. doi: 10.3109/00016348909020990.

  PMID: 2618602 BACKGROUND

• Demirel G, Guler H. The Effect of Uterine and Nipple Stimulation on Induction With Oxytocin and the Labor Process. Worldviews Evid Based Nurs. 2015 Oct;12(5):273-80. doi: 10.1111/wvn.12116.

  PMID: 26444882 BACKGROUND

• Jhirad A, Vago T. Induction of labor by breast stimulation. Obstet Gynecol. 1973 Mar;41(3):347-50. No abstract available.

  PMID: 4688251 BACKGROUND

• Shalev E, Weiner E, Tzabari A, Engelhard J, Zuckerman H, Shalev J, Serr DM. Breast stimulation in late pregnancy. Effect on prostaglandin secretion. Gynecol Obstet Invest. 1990;29(2):125-7. doi: 10.1159/000293317.

  PMID: 2335311 BACKGROUND

• Elliott JP, Flaherty JF. The use of breast stimulation to ripen the cervix in term pregnancies. Am J Obstet Gynecol. 1983 Mar 1;145(5):553-6. doi: 10.1016/0002-9378(83)91194-8.

  PMID: 6338721 BACKGROUND

• Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003392. doi: 10.1002/14651858.CD003392.pub2.

  PMID: 16034897 BACKGROUND

• Singh N, Tripathi R, Mala YM, Yedla N. Breast stimulation in low-risk primigravidas at term: does it aid in spontaneous onset of labour and vaginal delivery? A pilot study. Biomed Res Int. 2014;2014:695037. doi: 10.1155/2014/695037. Epub 2014 Nov 27.

  PMID: 25525601 BACKGROUND

• Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2001;(4):CD003392. doi: 10.1002/14651858.CD003392.

  PMID: 11687199 BACKGROUND

• Segal S, Gemer O, Zohav E, Siani M, Sassoon E. Evaluation of breast stimulation for induction of labor in women with a prior cesarean section and in grandmultiparas. Acta Obstet Gynecol Scand. 1995 Jan;74(1):40-1. doi: 10.3109/00016349509009941.

  PMID: 7856430 BACKGROUND

• Uvnas-Moberg K, Ekstrom-Bergstrom A, Berg M, Buckley S, Pajalic Z, Hadjigeorgiou E, Kotlowska A, Lengler L, Kielbratowska B, Leon-Larios F, Magistretti CM, Downe S, Lindstrom B, Dencker A. Maternal plasma levels of oxytocin during physiological childbirth - a systematic review with implications for uterine contractions and central actions of oxytocin. BMC Pregnancy Childbirth. 2019 Aug 9;19(1):285. doi: 10.1186/s12884-019-2365-9.

  PMID: 31399062 BACKGROUND

• Mashini IS, Devoe LD, McKenzie JS, Hadi HA, Sherline DM. Comparison of uterine activity induced by nipple stimulation and oxytocin. Obstet Gynecol. 1987 Jan;69(1):74-8.

  PMID: 3796923 BACKGROUND

MeSH Terms

Conditions

Uterine Rupture

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Pregnancy Complications; Genital Diseases; Rupture; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Maya Wolf, MD

  Galilee Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Wolf, MD

CONTACT

050-7887800; MayaW@gmc.gov.il

Osnat Sharon, CRC

CONTACT

052-3980209; OsnatS2@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Mother and Fetus Unit

Model Details: prospective, two-arm, active-comparator, randomized, controlled

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 22, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

IL (1)