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Comparision of two (foleys and foley with extra amniotic saline infusion) methods for induction of labour pains in pregnant women who are admitted for delivery

Induction of labor in women with unfavorable cervix: A randomised controlled study to assess the effectiveness of intracervical foley s catheter with extra amniotic saline infusion vs only foley s catheter - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081230
Enrollment
96
Registered
2025-02-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

Intervention1: extra amniotic saline infusion: extra amniotic saline infusion will be given along with intracervical foleys catheter insertion in intervention group and foleys catheter alone in the c

Sponsors

Amrusha Mangavilli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Women planned for induction of labor Singleton gestation Intact membrane. Cephalic presentation. Unfavourable cervix

Exclusion criteria

Exclusion criteria: Women who are already in labour. Previous c section Previous history of any uterine surgeries (myomectomy, hysterotomy etc) Non-reactive NST. 5. Low lying placenta / placenta previa/ vasa previa Placental abruption. Active genital herpes. Malpresentation. Contracted pelvis

Design outcomes

Primary

MeasureTime frame
1.Post foley expulsion- improvement in bishops score 2.Requirement for further inducing agents post foley expulsion {misoprostol/pge2 gel/oxytocin} 3.Induction to entry into active phase of labor 4.Induction to delivery interval Timepoint: BISHOP score more than 6—

Secondary

MeasureTime frame
1. Caesarean delivery rate 2. Incidence of chorioamnionitis 3. APGAR score at 1 & 5 mins 4. NICU admission rate Timepoint: bishops score more than 6—

Countries

India

Contacts

Public ContactAmrusha Mangavilli

AIIMS Mangalagiri

dr.vandanakamatham@gmail.com9787424158

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026