Clinical trial NCT01944787: Hydration and Rate of Cesarean Delivery Among Nulliparous
Official title: Intrapartum Hydration and Rate of Cesarean Delivery Among Nulliparous at > 37 Weeks: A Multicenter Randomized
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy
Lead sponsor: Chauhan, Suneet P., M.D.
Sponsor class: INDIV
First posted: 2013-09-18
Enrollment: 670
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: rate of cesarean section
timeFrame: 5 Years
Secondary outcomes:
measure: labor
timeFrame: 5 Years
Other outcomes:
measure: The rate of tachysystole (uterine contractions more than 5 in 10 minutes, n/%)
timeFrame: 5 Years
measure: The rate of non-reassuring fetal-heart reassuring tracing treated with terbutaline or other tocolytic agent (n/%)
timeFrame: 5 Years
measure: The indication for cesarean delivery (n/%) versus The indication for operative vaginal delivery (n/%)
timeFrame: 5 Years
measure: Maternal complications (as diagnosed by managing clinician, (n/%) for all):
timeFrame: 5 years
measure: Neonatal outcomes (as diagnosed by managing clinician, (n/%) for all):
timeFrame: 5 Years
measure: Time of Randomization to complete dilation/ minutes
timeFrame: 5 Years
measure: Time from complete cervical dilation to delivery of newborn/ minutes
timeFrame: 5 years
measure: Time from delivery of newborn to delivery of placenta/ minutes
timeFrame: 5 years
Locations:
city: Campbell
country: United States
facility: C A Combs MD PhD
state: California
Study officials:
name: Suneet P Chauhan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Obstetrix Medical Group
name: Andrew Combs, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: