N/A
N=318
A Trial of Intravenous Fluids During Labor
Ketosis
Bottom Line
View on ClinicalTrials.gov: NCT01110005 ↗Enrolled (actual)
318
Serious AEs
1.9%
Results posted
Mar 2017
Primary outcome: Primary: C-Section — 23; 18 Participants — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- D5 Lactated Ringer's Solution (D5LR) (Other); Lactated Ringer's Solution (LR) (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY C-Section |
23; 18 | 0.34 |
| SECONDARY Oxytocin Augmentation |
92; 88 | 0.40 |
| SECONDARY Time to Delivery |
12.8; 12.1 | 0.69 |
Summary
The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.
Eligibility Criteria
Inclusion Criteria
- Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation.
- These women will be in good health and candidates for vaginal delivery.
Exclusion Criteria
- Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc.
- Patients presenting for induction of labor or requiring induction upon admission.
- Patients presenting for scheduled cesarean section.
- Patients with any form of diabetes or glucose dysregulation condition.
- Concurrent use of steroids.
- Patients presenting in active labor with advanced cervical dilation (≥ 6 cm).
- Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).
Data sourced from ClinicalTrials.gov (NCT01110005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.