Hydration and Rate of Cesarean Delivery Among Nulliparous

Chauhan, Suneet P., M.D.

Status: Unknown

Conditions: Pregnancy

Treatments: Other: IV Hydration at 250cc hour; Other: Routine

Study type: Interventional

Identifiers

NCT01944787

12-05-SP-50

Details and patient eligibility

About

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.

Full 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.

Enrollment: 670 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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670 participants in 2 patient groups

Routine

Active Comparator group

Description:

IV Hydration at 125 cc hour

Treatment:

Other: Routine

Intervention

Experimental group

Description:

IV Hydration at 250 cc hour

Treatment:

Other: IV Hydration at 250cc hour