Natural Cervical Ripening to Prevent Pharmacological Induction of Labor - a Pilot Study.

NCT07587632 | Recruiting

• 1 other identifier: 2025-01367
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

As of today, around 25% of all vaginal births happen after induction of labor (IOL). The internal guidelines of the University Hospital Zurich currently recommend pregnant women with a non-insulin dependent gestational diabetes an IOL around term. One possibility to prevent an IOL and increase the chance for a spontaneous onset of birth is a ripening of the cervix by alternative methods in an outpatient setting. The primary objective of this study is to evaluate the effect of natural cervical ripening methods on the time interval between 37 weeks (beginning of the intervention) and the onset of spontaneous labor.

Conditions

Pregnancy; Induction of Labor; Gestational Diabetes Mellitus (GDM)

Keywords

gestational Diabetes; Induction of labor; cervical ripening; pregnancy; colostrum banking; membrane sweeping

Outcome Measures

Primary Outcomes (1)

• the time interval between 37/0 weeks of gestation and the onset of labor.

  Between 37/0 weeks of gestation until the onset of labor

Study Arms (2)

Study Intervention

EXPERIMENTAL

Membrane sweeping twice weekly plus intensified breast massage in addition to colostrum banking

Procedure: Membrane sweaping and Breast massage

Control arm

NO INTERVENTION

Standard of care treatment including colostrum banking

Interventions

Membrane sweaping and Breast massage PROCEDURE

Study intervention: * Membrane sweeping: Circular movements with the finger on the lower uterine segment to separate the lower uterine segment from the membranes during a digital vaginal examination. Twice per week, performed by medical personnel. * Breast massage: Massaging the breast with gentle pressure for a few minutes, followed by a compression towards the nipple using the thumb and index finger in the C position. Repeating this sequence for 60 minutes in total, while alternating the breast every 5 minutes. Performed by the patient herself on 3 days per week (3 times 60 minutes). * Colostrum harvesting: The current standard of care at the Department of Obstetrics of the University Hospital Zurich for pregnant women with a non-insulin-dependent gestational diabetes, beginning at 36 weeks of gestation. Massaging the breast with gentle pressure for a few minutes, followed by a compression towards the nipple using the thumb and index finger in the C position. Repeating this sequence

Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton gestation
• Non-insulin dependent, dietetically managed gestational diabetes
• Greater than or equal to 34 weeks.
• Planned vaginal birth at the University Hospital of Zurich
• Planned IOL for 40 weeks of gestation.
• Communication in German and/or English language possible.

You may not qualify if:

• Pregnant women with multiple gestation
• Fetal macrosomia \>95th percentile
• Intrauterine growth restriction \<3rd percentile
• Already in labor (regular contractions or premature rupture of membranes (PROM)
• Patients scheduled for IOL before 40 weeks
• Insulin-dependent diabetes
• Planned cesarean section
• Planned birth in an external hospital
• Inability to follow the procedures e.g. due to language problems, psychological disorders

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (3)

• Witkop CT, Neale D, Wilson LM, Bass EB, Nicholson WK. Active compared with expectant delivery management in women with gestational diabetes: a systematic review. Obstet Gynecol. 2009 Jan;113(1):206-217. doi: 10.1097/AOG.0b013e31818db36f.

  PMID: 19104376 BACKGROUND

• Zanardo V, Bertin M, Sansone L, Felice L. The adaptive psychological changes of elective induction of labor in breastfeeding women. Early Hum Dev. 2017 Jan;104:13-16. doi: 10.1016/j.earlhumdev.2016.10.007. Epub 2016 Nov 30.

  PMID: 27914274 BACKGROUND

• Declercq ER, Sakala C, Corry MP, Applebaum S, Herrlich A. Major Survey Findings of Listening to Mothers(SM) III: Pregnancy and Birth: Report of the Third National U.S. Survey of Women's Childbearing Experiences. J Perinat Educ. 2014 Winter;23(1):9-16. doi: 10.1891/1058-1243.23.1.9.

  PMID: 24453463 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Verena Bossung, PD. Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Verena Bossung, PD Dr. med.

CONTACT

+44 43 253 28 47; verena.bossung@usz.ch

Nicole Ochsenbein, Prof. Dr. med

CONTACT

+41 43 255 51 01; Nicole.Ochsenbein@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: Monocentric, prospective, randomized-controlled trial.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

CH (1)