Pregnancy
Conditions
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.
Interventions
OTHERRoutine
IV Hydration at 125 cc hour
OTHERIV Hydration at 250cc hour
IV Hydration at 250 cc hour
Sponsors
Chauhan, Suneet P., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of cesarean section | 5 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| labor | 5 Years | The secondary objectives of this randomized trial are to compare the 2 groups regarding: Time from randomization to delivery (minutes) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Time from delivery of newborn to delivery of placenta/ minutes | 5 years | — |
| Neonatal outcomes (as diagnosed by managing clinician, (n/%) for all): | 5 Years | 1. Apgar score at 1 and 5 min 2. Birth weight (grams) 3. Gender (male/female/unknown) 4. Umbilical arterial pH if available (pH units) 5. Umbilical arterial base excess if available (mmol/L) 6. Admission to neonatal intensive care unit (n/%) 7. Indication for NICU admission (n/%) 8. Duration of hospitalization (days) 9. 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/%) 10. Mortality (n/%) |
| Time of Randomization to complete dilation/ minutes | 5 Years | — |
| Maternal complications (as diagnosed by managing clinician, (n/%) for all): | 5 years | 1. chorioamnionitis 2. endometritis 3. wound infection 4. wound disruption 5. blood transfusion |
| Time from complete cervical dilation to delivery of newborn/ minutes | 5 years | — |
Countries
United States
Contacts
Primary ContactSuneet Chauhan, MD
Outcome results
None listed