Hydration and Rate of Cesarean Delivery Among Nulliparous
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/2/2016 |
| Start Date: | September 2013 |
| End Date: | July 2018 |
| Contact: | Suneet Chauhan, MD |
| Email: | mfmchauhan@gmail.com |
| Phone: | 757-672-5955 |
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.
vs. 125ml/hrs would decrease the rate of primary cesarean section.
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.
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.
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)
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