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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine | Active Comparator | IV Hydration at 125 cc hour |
|
| Intervention | Experimental | IV Hydration at 250 cc hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine | Other | IV Hydration at 125 cc hour |
| |
| IV Hydration at 250cc hour |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:• Non-anomalous singleton
Exclusion Criteria:• Not in the inclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suneet Chauhan, MD | Contact | 757-672-5955 | mfmchauhan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Suneet P Chauhan, MD | Principal Investigator | |
| Andrew Combs, MD PhD | Obstetrix Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C A Combs MD PhD | Campbell | California | 95008 | United States |
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| Other |
IV Hydration at 250 cc hour |
|
| 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): |
| 5 years |
| Neonatal outcomes (as diagnosed by managing clinician, (n/%) for all): |
| 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 |