Hydration and Rate of Cesarean Delivery Among Nulliparous

Not Applicable

• Conditions: Pregnancy
• Interventions: Other: Routine; Other: IV Hydration at 250cc hour

• Registration Number: NCT01944787
• Lead Sponsor: Chauhan, Suneet P., M.D.

Brief Summary

The hypothesis of the present study is the hydration of nulliparous women with 250ml/hour vs. 125ml/hrs would decrease the rate of primary cesarean section.

Detailed Description

For this non-blinded randomized clinical trial (RCT) we will recruit approximately 670 women which meet the inclusion criteria across three sites (Eastern Virginia Medical School (EVMS), University of Arkansas for Medical Sciences (UAMS) and Obstetrix Medical Group, in California). When the patient is being scheduled for induction by her physician or when she presents to L\&D for induction or in labor, but her cervical dilation on admission is less than 4 cm, the participants will be consented, and then randomized into a study intervention group. Both groups will receive maintenance IV hydration with Lactated Ringer's (LR) solution: Group I will receive LR at 125 ml/hr and group II will receive LR at 250ml/hr. Other than the rate of maintenance IV infusion, the two groups will receive routine intrapartum care.

Study Timeline

• Status Verified: 2013-09
• Study Start: 2013-09
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-17
• Last Update Submitted: 2013-09-17
• Study First Posted: 2013-09-18
• Last Update Posted: 2013-09-18
• Primary Completion: 2018-01
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 670

Inclusion Criteria

• Non-anomalous singleton

• Nulliparous (no prior delivery after 20 weeks)
• Presenting at ≥37 weeks of gestation
• Presenting for anticipated induction of labor or spontaneous labor (regular contractions for more than 2 hours), but cervical dilation less than 4 cm
• Rupture of membranes
• Expected to deliver at one of the participating hospitals

Exclusion Criteria

• Not in the inclusion criteria

• Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)
• Diabetes mellitus-gestational or pre-gestational
• Enrollment in another randomized clinical trial
• Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)
• Hypertension (chronic or pregnancy induced) before randomization
• HIV (human immunodeficiency virus)
• Placenta previa / 3rd trimester bleeding
• Renal insufficiency (serum creatinine > 1.5 mg/dL)
• Restrictive lung disease
• Seizure disorder on medication
• Thyroid disease on medication
• Any contraindications to vaginal delivery (breech, active herpes, schedule cesarean, abnormal fetal heart tracing)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine	Routine	IV Hydration at 125 cc hour
Intervention	IV Hydration at 250cc hour	IV Hydration at 250 cc hour

Primary Outcome Measures

Name	Time	Method
rate of cesarean section	5 Years	The primary objective of this multi-center RCT is to determine if hydration with 250 ml/hr, when compared to traditional 125 ml/hr, significantly decreases the rate of primary cesarean delivery nulliparous.

Secondary Outcome Measures

Name	Time	Method
labor	5 Years	The secondary objectives of this randomized trial are to compare the 2 groups regarding: Time from randomization to delivery (minutes)

Trial Locations

Locations (1)

C A Combs MD PhD; 🇺🇸 Campbell, California, United States