Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01255839
Other study ID # H-KA-01177-M
Secondary ID
Status Completed
Phase Phase 4
First received December 6, 2010
Last updated December 7, 2010
Start date December 2002
Est. completion date December 2010

Study information

Verified date January 2002
Source Glostrup University Hospital, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

The use of prostaglandin E2 (PGE2) for induction of labour in women with unfavourable cervices is well-established1. There are, however, potential side effects to prostaglandins, in particular the risk of uterine hypertonicity which may affect fetal outcome. In theory a mechanical ripening based on dilatation of the cervix as well as induction of production of endogenous prostaglandin has potentially less influence on the fetal outcome but a Cochrane review from 2001 scrutinized studies on mechanical ripening versus placebo/no treatment or prostaglandin E2. They conclude there is insufficient data to evaluate the effectiveness in terms of likelihood of vaginal delivery in 24 hours, and emphasise the need for large sample size studies and substantive outcomes. Two later randomised studies compared mechanical ripening to PGE2 and found discrepant results regarding time from induction to delivery.

The primary purpose of the present study was in a randomized design to compare the efficacy of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) on induction of labour, duration of birth and fetal outcome. Secondary analyses were to evaluate the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction.


Description:

Read more »
Read more »

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Device:
Double Balloon
The Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina.
Drug:
Minprostin
The prostaglandin 2 minprostin (3mg) was applied vaginally

Locations

Country Name City State
Denmark Glostrup University Hospital Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary success of induction of labour, duration of birth and fetal outcome The primary purpose of the present study was in a randomized design to compare the efficacy of double-balloon catheter versus vaginal PGE2 (minprostin 3 mg) . at birth No
Secondary the results for various subgroups, i.e. primipara/multipara, gemelli, vaginal birth after caesarean, preterm birth and intra uterine growth restriction at birth No
See also
  Status Clinical Trial Phase
Completed NCT04238741 - Audio-recording of Consent for Anaesthesia for Elective Caesarean Section N/A
Terminated NCT03638011 - A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine Phase 4
Completed NCT01718236 - Modern Myorelaxation Procedure and Reversal of Neuromuscular Blockade With General Anesthesia for Caesarean Section Phase 4
Completed NCT03199170 - Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section N/A
Completed NCT03309163 - Effect of Tramadol in Prevention of Postpartum Depression Phase 4
Completed NCT03711552 - Validation of an Obstetric QoR Score and to Establish Its MCID.
Not yet recruiting NCT05583214 - Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia Phase 4
Recruiting NCT06070844 - Yoga Nidra and Pain After Caesarean Section N/A
Recruiting NCT06070792 - Neurolinguistic Programming, Progressive Muscle Relaxation Exercises, and Breastfeeding N/A
Recruiting NCT06135961 - Intrapartum Non-invasive Electrophysiological Monitoring N/A
Terminated NCT04435496 - Study to Evaluate the Learning Curve to Anchor GYN-CS® Device N/A
Completed NCT00916812 - Sensitivity of Hyomental Distance Ratio as a Single Predictor of Difficult Intubation in Obstetrics
Completed NCT05520580 - Effect of Mother's Push at Cesarean Delivery Mother's PUSHING AT CS A RANDOMIZED CONTROLLED TRIAL N/A
Recruiting NCT02755168 - External Pop-Out Technique Versus Classic Head Extraction During Cesarean Section N/A
Completed NCT02285569 - The Pleth Variability Index and Hypotension at Caesarean Under Spinal. N/A
Completed NCT01210300 - Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section N/A
Completed NCT03653442 - Non Invasive Haemodynamics in Neuraxial Anaesthesia Hypotension
Completed NCT03134677 - The Effects of Different Anesthetic Techniques on QT, Corrected QT (QTc), and P Wave Dispersions in Cesarean Section Phase 4
Not yet recruiting NCT05446311 - Naldebain® Extended-release Injection After Cesarean Section in Pain Management
Completed NCT01278238 - Optimization of Hemodynamic Conditions During Caesarean Section Under Spinal Anaesthesia N/A