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

Overview

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.

Detailed description

Approximately 25% of vaginal births currently occur following induction of labor (IOL). At the University Hospital Zurich, internal guidelines recommend IOL at 40 weeks of gestation for women with non-insulin-dependent, diet-controlled gestational diabetes. However, IOL may be associated with side effects and a less positive birth experience. Alternative, natural methods for cervical ripening in an outpatient setting may help promote spontaneous labor onset and reduce the need for medical induction.

This investigator-initiated, mono-centric, prospective, randomized controlled trial aims to evaluate the effectiveness, safety, and feasibility of natural cervical ripening methods, specifically nipple stimulation (breast massage/colostrum harvesting) and membrane sweeping. The primary objective is to assess whether these interventions shorten the time from 37 weeks of gestation (start of intervention) to the onset of spontaneous labor.

The primary endpoint is the time interval between 37 weeks' gestation and spontaneous onset of labor. Secondary endpoints include the rate of spontaneous labor before planned IOL, oxytocin use during childbirth, use of pharmacological induction agents, duration of hospitalization, postpartum hemorrhage (\>500 ml), mode of birth, patient satisfaction with the intervention/induction and birth experience, and neonatal outcomes.

The study includes 74 pregnant women aged ≥18 years with singleton pregnancies, diet-controlled gestational diabetes, planned vaginal birth, and scheduled IOL at 40 weeks, who can communicate in German or English and have provided informed consent. Key exclusion criteria include multiple gestation, fetal growth abnormalities, insulin-dependent diabetes, planned cesarean section, onset of labor prior to enrollment, or inability to comply with study procedures.

Participants are randomized to either an intervention group or a control group. The intervention group receives membrane sweeping twice weekly by medical personnel from 37 weeks, breast massage/nipple stimulation performed by the participant for 60 minutes on three days per week, and standard colostrum harvesting beginning at 36 weeks. The control group receives standard care only, consisting of colostrum harvesting twice daily from 36 weeks, which is already routine practice at the institution.

Data collection includes questionnaires during the intervention phase (assessing experience, compliance, and side effects) and after delivery (assessing satisfaction with the intervention or IOL and overall birth experience). Recruitment takes place during routine prenatal visits or at the lactation outpatient clinic of the University Hospital Zurich. Following informed consent and confirmation of eligibility, participants are enrolled and randomized.

The anticipated benefits include increased spontaneous onset of labor, reduced need for IOL and oxytocin, decreased postpartum hemorrhage, and improved maternal satisfaction with the birth experience. Given the natural nature of the interventions, risks are considered low, primarily mild vaginal bleeding or discomfort during membrane sweeping.

Interventions

• Procedure Membrane sweaping and Breast massage
  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 brea

Primary outcome measures

• the time interval between 37/0 weeks of gestation and the onset of labor. [Time frame: Between 37/0 weeks of gestation until the onset of labor]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Switzerland · 1 center

• University Hospital Zurich — Zurich

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07587632 · 2025-01367

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗