Hydration and Rate of Cesarean Delivery Among Nulliparous

Pregnancy Clinical Trial

Official title:

Intrapartum Hydration and Rate of Cesarean Delivery Among Nulliparous at > 37 Weeks: A Multicenter Randomized

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01944787
• Other study ID #: 12-05-SP-50
• Status: Not yet recruiting
• Phase: N/A
• First received: September 6, 2013
• Last updated: September 17, 2013
• Start date: September 2013
• Est. completion date: July 2018

Study information

• Verified date: September 2013
• Source: Chauhan, Suneet P., M.D.
• Contact: Suneet Chauhan, MD
• Phone: 757-672-5955
• Email: mfmchauhan[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 670
• Est. completion date: July 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Routine
IV Hydration at 125 cc hour
• IV Hydration at 250cc hour
IV Hydration at 250 cc hour

Locations

Country	Name	City	State
United States	C A Combs MD PhD	Campbell	California

Sponsors (1)

Lead Sponsor	Collaborator
Chauhan, Suneet P., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The rate of tachysystole (uterine contractions more than 5 in 10 minutes, n/%)		5 Years	No
Other	The rate of non-reassuring fetal-heart reassuring tracing treated with terbutaline or other tocolytic agent (n/%)		5 Years	No
Other	The indication for cesarean delivery (n/%) versus The indication for operative vaginal delivery (n/%)		5 Years	Yes
Other	Maternal complications (as diagnosed by managing clinician, (n/%) for all):	chorioamnionitis; endometritis; wound infection; wound disruption; blood transfusion	5 years	No
Other	Neonatal outcomes (as diagnosed by managing clinician, (n/%) for all):	Apgar score at 1 and 5 min; Birth weight (grams); Gender (male/female/unknown); Umbilical arterial pH if available (pH units); Umbilical arterial base excess if available (mmol/L); Admission to neonatal intensive care unit (n/%); Indication for NICU admission (n/%); Duration of hospitalization (days); 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/%); Mortality (n/%)	5 Years	No
Other	Time of Randomization to complete dilation/ minutes		5 Years	No
Other	Time from complete cervical dilation to delivery of newborn/ minutes		5 years	No
Other	Time from delivery of newborn to delivery of placenta/ minutes		5 years	No
Primary	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	No
Secondary	labor	The secondary objectives of this randomized trial are to compare the 2 groups regarding: Time from randomization to delivery (minutes)	5 Years	No