A randomized controlled trial to study the effect of intravenous hydration on the course of labor

Phase 3

• Conditions: Effect of adequate hydration on duration of active labor

• Registration Number: CTRI/2008/091/000003
• Lead Sponsor: Christian Medical College and Hospital,Vellore

Brief Summary

This study is a randomized,double blind,parallel group,active cotrolled trial to study the effect of intravenous hydration on the course of labor.There will be 3 groups receiving IV Ringer125ml/hr,250ml/hr and oral hydration respectively.Each group will have 60 patients and the study is conducted at C.M.C.Hospital,Vellore,India over 6 months.The primary outcomes will include total duration of labour in minutes, frequency of prolonged labour - > 12 hours, incidence of LSCS due to failure to progress,frequency of oxytocin administration for augmentation and incidence of operative vaginal delivery.The secondary outcomes will be Maternal and neonatal complications like chorioamnionitis,endometritis,wound infection, PPH,pulmonary edema,NICU admissions and sepsis.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

1. Primigravida 2) Uncomplicated Pregnancies3) Spontaneous onset of labour4) Singleton gestation5) Cephalic presentation6) In active labour with cervical dilation 3 cms 7) Pregnancy duration more than or equal to 37 weeks.

Exclusion Criteria

NonVertex presentationHigh risk pregnancyPrevious LSCSInduction of labour TwinsChorioamnionitisRenal/cardiac disease or pre eclampsia.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total duration of labour in minutes Frequency of prolonged labour - > 12 hoursIncidence of LSCS due to failure to progressFrequency of oxytocin administration for augmentation Incidence of operative vaginal delivery	6 months

Secondary Outcome Measures

Name	Time	Method
Maternal and neonatal complications -Chorioamnionitis -Endometritis-Wound infection-PPH-Pulmonary oedema -NICU admissions and sepsis	6 months

Trial Locations

Locations (1)

Department of Obstetrics & Gynaecology,Christian Medical College and Hospital; 🇮🇳 Vellore, TAMIL NADU, India

Department of Obstetrics & Gynaecology,Christian Medical College and Hospital

🇮🇳Vellore, TAMIL NADU, India

Dr.Kavitha Abraham

Principal investigator

04162282314

alphakavi@hotmail.com