A trial comparing the use of foleys catheter with and without weights on induction of labour

Completed

Conditions: Complications of labor and delivery, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery,

Registration Number: CTRI/2018/10/016154

Lead Sponsor: Christian Medical College

Brief Summary: This is a prospective randomized controlled trial which will be done in pregnant women at term with no risk factors. Women in the arm randomized to induction with a foleys catheter will be induced with the foleys catheter inflated with 30 ml sterile water. The other group will be induced with foleys catheter inflated with 30 ml sterile water. The end of this foleys catheter will be attached to a 500 gm weight (500ml of 5% dextrose). These women will then be induced with oxytocin after 12 hours of inserting the foleys catheter if they do not have uterine contractions. After informed consent, women will be recruited from labour room and randomized to either of the groups. Data regarding duration of labour, fever, CTG abnormalities, neonatal morbidity etc., will be collected. The data will be analyzed to compare safety and efficacy in both groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 398

Inclusion Criteria

1.Singleton pregnany 2.Primigravida and multigravida needing induction at 39 weeks and beyond 3.Cephalic presentation 4.Bishops score less than or equal to 4.

Exclusion Criteria

1.Previous LSCS 2.Previous endometritis 3.Any high risk factors requiring induction at <39 weeks.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of LSCS for failed induction	Time from induction to vaginal delivery or Caesarean delivery

Secondary Outcome Measures

Name	Time	Method
1. Effectiveness	2. Complications

Trial Locations

Locations (1): Christian Medical College and Hospital
🇮🇳
Vellore, TAMIL NADU, India
Christian Medical College and Hospital
🇮🇳Vellore, TAMIL NADU, India
Anne George Cherian
Principal investigator
9487760904
annegc97@yahoo.co.in