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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00984347
Other study ID # 280808-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 23, 2009
Last updated September 24, 2009
Start date November 2009
Est. completion date December 2010

Study information

Verified date September 2009
Source Hadassah Medical Organization
Contact Yael Sciaky-Tamir, MD
Phone +972-2-5844111
Email yaels@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of the trial is to compare nipple stimulation with a breast pump to pitocin for induction of labor in term pregnancies.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date December 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- 18 years and older

- completed 37 weeks gestation

- singleton pregnancy

- reassuring fetal heart rate at admission monitor

Exclusion Criteria:

- multiple pregnancies

- known fetal malformations

- non reassuring NST

- polyhydramnios (AFI>220)

- oligohydramnios

- PET

- IUGR

- macrosomia (EFW >4000g)

- antepartum bleeding

- maternal fever

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Oxytocin
For low risk group (women at deliveries 1-5): IV oxytocin 10IU/1000ml standard sol. starting at 2MU/MIN and augmenting 2MU every 20 min. For high risk group (grandmultiparas [6th delivery and up] or women with a previous cesarean section) IV oxytocin 5IU/1000ml standard sol. starting at 1MU/MIN augmenting 1MU every 20 MIN - in accordance with the department's protocol
Procedure:
breast pump nipple stimulation
breast pump calibrated at lowest suction strength, operated alternately: 15 min one breast, 15 min second breast, 15 min rest

Locations

Country Name City State
Israel Hadassah University Hospital Mt. Scopus Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary time from induction to delivery 24h No
Secondary fetal distress (monitor assessment, cord ph) 24 h No
Secondary cesarean section rate 24h No
See also
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Completed NCT05827731 - Cervical Double Balloon Combined With Oxytocin N/A
Recruiting NCT04035382 - BMI-Associated Labor Induction: A Prospective Trial N/A
Withdrawn NCT00771511 - Cervical Capsaicin for Labor Induction and Pain Relief Phase 4
Recruiting NCT04075630 - Observatory on Artificial Labour-induction Methods and Measuring Immediate Postpartum Maternal Satisfaction
Active, not recruiting NCT04573517 - Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor N/A
Withdrawn NCT05257187 - Foley Catheter Induction N/A
Recruiting NCT03016442 - Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening Phase 2
Completed NCT04596397 - Oral Misoprostol for Outpatient Induction of Labor N/A
Completed NCT03504670 - Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial N/A
Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT01402050 - Foley Catheter Versus Cervidil for Induction of Labor at Term N/A
Completed NCT00529295 - Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term Phase 3
Completed NCT00346840 - Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour Phase 2
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A
Withdrawn NCT03218735 - Early Term Delivery Versus Expectant Management of the Large for Gestational Age Fetus N/A
Completed NCT02639429 - Cervical Ripening for Obese Women: A Randomized, Comparative Effectiveness Trial Phase 4