Hydration and Rate of Cesarean Delivery Among Nulliparous

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

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.

Study Overview

• Status: Unknown
• Conditions: Pregnancy
• Intervention / Treatment: Other: Routine; Other: IV Hydration at 250cc hour

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 Type: Interventional
• Enrollment (Anticipated): 670
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • C A Combs MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Routine; IV Hydration at 125 cc hour	Other: Routine; IV Hydration at 125 cc hour
EXPERIMENTAL: Intervention; IV Hydration at 250 cc hour	Other: IV Hydration at 250cc hour; IV Hydration at 250 cc hour

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of tachysystole (uterine contractions more than 5 in 10 minutes, n/%)		5 Years
The rate of non-reassuring fetal-heart reassuring tracing treated with terbutaline or other tocolytic agent (n/%)		5 Years
The indication for cesarean delivery (n/%) versus The indication for operative vaginal delivery (n/%)		5 Years
Maternal complications (as diagnosed by managing clinician, (n/%) for all):	chorioamnionitis; endometritis; wound infection; wound disruption; blood transfusion	5 years
Neonatal outcomes (as diagnosed by managing clinician, (n/%) for all):	Apgar score at 1 and 5 min; Birth weight (grams); Gender (male/female/unknown); Umbilical arterial pH if available (pH units); Umbilical arterial base excess if available (mmol/L); Admission to neonatal intensive care unit (n/%); Indication for NICU admission (n/%); Duration of hospitalization (days); Morbidity defined as one or more of the following as diagnosed by managing physician: Respiratory Distress Syndrome (RDS), Intraventricular Hemorrhage (IVH) grade III/ IV, Necrotizing Enterocolitis (NEC), proven sepsis,seizures (n/%); Mortality (n/%)	5 Years
Time of Randomization to complete dilation/ minutes		5 Years
Time from complete cervical dilation to delivery of newborn/ minutes		5 years
Time from delivery of newborn to delivery of placenta/ minutes		5 years

Collaborators and Investigators

• Sponsor: Chauhan, Suneet P., M.D.
• Investigators: Principal Investigator: Suneet P Chauhan, MD; Principal Investigator: Andrew Combs, MD PhD, Obstetrix Medical Group

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ANTICIPATED): January 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (ESTIMATE): September 18, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 12-05-SP-50