Hydration and Rate of Cesarean Delivery Among Nulliparous

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intrapartum Hydration and Rate of Cesarean Delivery Among Nulliparous at > 37 Weeks: A Multicenter Randomized

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Routine
* Other: IV Hydration at 250cc hour


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine<br>IV Hydration at 125 cc hour | Other: Routine<br>* IV Hydration at 125 cc hour<br>|
| Experimental: Intervention<br>IV Hydration at 250 cc hour | Other: IV Hydration at 250cc hour<br>* IV Hydration at 250 cc hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of cesarean section | 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. | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| labor | The secondary objectives of this randomized trial are to compare the 2 groups regarding: Time from randomization to delivery (minutes) | 5 Years |