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Assessing a Predicted Time to Delivery in the Context of Cervical Ripening With Dinoprostone Vaginal Insert

NCT03482531 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2018-05-30

No results posted yet for this study

Summary

Induction of labor is a common obstetric procedure that is routinely performed worldwide. However, when cervical conditions are not favorable (bishop \<6), induction of labor is preceded by cervical ripening, usually with prostaglandins. The method of ripening most commonly used in France (89% of maternity wards) is the dinoprostone vaginal insert. In the majority of hospitals in France, dinoprostone vaginal inserts are usually placed in the morning, because of the higher availability of personnel (midwives and nurses). However, morning placement might increase the likelihood of the delivery occurring at night, since the mean interval between the insert placement and delivery is about 13 to 20 hours. Many studies have now shown that the risk of obstetrical complications, as well as neonatal morbidity and mortality is increased when deliveries occur at night. Several factors have been suggested behind the increased morbidity at night, including the lower number of personnel working, the fatigue associated with night work and the disruption of the circadian rhythm, and the insufficient supervision of residents.

Very few studies have evaluated the importance of the timing of placement of the intravaginal dinoprostone insert, and its influence on the occurrence of night deliveries. Some investigators have recently performed a retrospective study at Angers university hospital that assessed the time interval between placing the dinoprostone vaginal insert and delivery, as well as the factors impacting the time to delivery, and found that nulliparity, obesity, a closed cervix on initial examination, and intact membranes at the time of insertion increased the time to delivery. Moreover, the investigators proposed a regression equation that allows to calculate the mean time from insert placement to delivery for each patient, and have decided to incorporate it in the routine practice.

The investigators have decided to analyze the validity of the mathematical model. The consequence would be, thanks to a personalized timing for placement of dinoprostone vaginal insert based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes), a decreased number of deliveries occurring between 12 p.m. and 6 a.m.

Conditions

  • Dinoprostone Vaginal Insert

Interventions

OTHER

mathematical model

mathematical model: regression equation that calculates the mean time from insert placement to delivery for each patient, based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes)

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-11-01
Completion
2019-11-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03482531 on ClinicalTrials.gov