Methods of Labor Induction & Perinatal Outcomes

Status Completed

Clinical Trial Summary

Since it is a frequent intervention in Obstetrics, labor induction is rarely evaluated from national population-based cohorts. The study aims to assess the frequency of different induction methods used in France from a prospective population-based cohort of women with an induced labor. Maternal, fetal and neonatal outcomes will be compared between the different induction methods. Moreover the adhesion to national clinical guidelines concerning the induction of labor will be studied from this population-based cohort.

Finally the women satisfaction will be assessed according to the induction method used.

Clinical Trial Description

Labor induction concerns about 22% of deliveries in France, according to the the 2010 French national perinatal survey. Labor induction could be associated with a higher risk of fetal and maternal complications, justifying its assessment from a population-based prospective cohort.

Several methods (dinoprostone, oxytocin, misoprostol, balloon catheter …) are used to induce labor in France. To decide and perform labor inductions, physicians can refer to published guidelines according to specific obstetrical situations. But many of these guidelines are based on a low level of evidence probably explaining observed differences in practices.

In some cases, labor induction is decided without indication, and women's involvement in this kind of decisions is not really evaluated.

The objectives are therefore :

- To evaluate the frequency of use of different methods for labor induction according to the cervix status, the indication of labor induction, and the place of the delivery.

- To analyse maternal, fetal and neonatal issues according to the different induction methods, taken into account the induction indications

- To compare current practices of labor induction to published national guidelines and to assess the impact of deviations from these guidelines on maternal and neonatal issues

- To assess women's satisfaction regarding the indication and the induction method used. ;

Study Design

Related Conditions & MeSH terms

Induction of Labor

Clinical Trial Details

NCT number	NCT02477085
Study type	Observational
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase
Start date	November 2015
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01127581` - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery	Phase 3
Completed	`NCT01139801` - Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon	N/A
Active, not recruiting	`NCT06324279` - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting	`NCT05864326` - Heated Saline in Cervical Balloon for Labor Induction, a RCT	N/A
Active, not recruiting	`NCT06056141` - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter	Phase 4
Completed	`NCT04529837` - Ultrasound Assessment of DILAPAN-S
Completed	`NCT02098421` - Foley Labor Induction Trial at Term and in PROM	Phase 1
Completed	`NCT03138252` - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin	Phase 3
Recruiting	`NCT01720394` - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert	Phase 4
Completed	`NCT00451308` - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml	Phase 4
Not yet recruiting	`NCT05511727` - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening	N/A
Recruiting	`NCT02762942` - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor	Phase 4
Completed	`NCT01283022` - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)	Phase 2
Recruiting	`NCT00684606` - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor	N/A
Recruiting	`NCT05759364` - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain	N/A
Recruiting	`NCT03854383` - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women	Phase 2
Completed	`NCT01428037` - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor	Phase 3
Terminated	`NCT03752073` - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix	N/A
Recruiting	`NCT03045939` - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours	N/A
Completed	`NCT03976037` - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Methods of Labor Induction and Perinatal Outcomes — MEDIP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms