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Hydration and Rate of Cesarean Delivery Among Nulliparous

NCT ID: NCT01944787

Last Updated: 2013-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-07-31

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.

Conditions

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Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Routine

IV Hydration at 125 cc hour

Group Type ACTIVE_COMPARATOR

Routine

Intervention Type OTHER

IV Hydration at 125 cc hour

Intervention

IV Hydration at 250 cc hour

Group Type EXPERIMENTAL

IV Hydration at 250cc hour

Intervention Type OTHER

IV Hydration at 250 cc hour

Interventions

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Routine

IV Hydration at 125 cc hour

Intervention Type OTHER

IV Hydration at 250cc hour

IV Hydration at 250 cc hour

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chauhan, Suneet P., M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suneet P Chauhan, MD

Role: PRINCIPAL_INVESTIGATOR

Andrew Combs, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Obstetrix Medical Group

Locations

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C A Combs MD PhD

Campbell, California, United States

Site Status

Countries

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United States

Central Contacts

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Suneet Chauhan, MD

Role: CONTACT

Phone: 757-672-5955

Email: [email protected]

Facility Contacts

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C A Combs, MD PhD

Role: primary

kimberly m mallory, RNC

Role: backup

Other Identifiers

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12-05-SP-50

Identifier Type: -

Identifier Source: org_study_id