Hydration and Rate of Cesarean Delivery Among Nulliparous
Intrapartum Hydration and Rate of Cesarean Delivery Among Nulliparous at > 37 Weeks: A Multicenter Randomized
1 other identifier
interventional
670
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Sep 2013
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedSeptember 18, 2013
September 1, 2013
4.3 years
September 6, 2013
September 17, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
labor
5 Years
Other Outcomes (8)
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
- +5 more other outcomes
Study Arms (2)
Routine
ACTIVE COMPARATORIV Hydration at 125 cc hour
Intervention
EXPERIMENTALIV Hydration at 250 cc hour
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
C A Combs MD PhD
Campbell, California, 95008, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Suneet P Chauhan, MD
- PRINCIPAL INVESTIGATOR
Andrew Combs, MD PhD
Obstetrix Medical Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDIV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2013
First Posted
September 18, 2013
Study Start
September 1, 2013
Primary Completion
January 1, 2018
Study Completion
July 1, 2018
Last Updated
September 18, 2013
Record last verified: 2013-09