NCT02989571

Brief Summary

The objective of this study is to compare the effects of intravenous fluid rate on the course of labor in nulliparous patients who are undergoing labor induction and have an unfavorable cervix. The primary hypothesis is that an increased rate of intravenous fluids will shorten the length of labor in patients undergoing induction with an unfavorable cervix.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Mar 2016

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

4.8 years

First QC Date

January 21, 2016

Last Update Submit

January 18, 2023

Conditions

Labor; Forced or Induced, Affecting Fetus or Newborn

Outcome Measures

Primary Outcomes (1)

  • Length of labor (hours of duration)

    Measured via chart review

    within the first 7 days (plus or minus 3 days) after delivery

Secondary Outcomes (11)

  • Epidural use (yes or no)

    within the first 7 days (plus or minus 3 days) after delivery

  • Oxytocin use (yes or no)

    within the first 7 days (plus or minus 3 days) after delivery

  • Mode of Delivery (vaginal delivery, operative vaginal delivery, or cesarean)

    within the first 7 days (plus or minus 3 days) after delivery

  • Indication for operative or cesarean delivery (e.g. Nonreassuring fetal tracing, arrest of labor, other)

    within the first 7 days (plus or minus 3 days) after delivery

  • Maternal infectious or other morbidity (Yes or No)

    within the first 7 days (plus or minus 3 days) after delivery

  • +6 more secondary outcomes

Study Arms (2)

Group 1 - Placebo Arm

PLACEBO COMPARATOR

Intravenous normal saline administered at 125ml/hr

Drug: Intravenous normal saline administered at 125ml/hr

Group 2 - Intervention Arm

ACTIVE COMPARATOR

Intravenous normal saline administered at 250ml/hr

Drug: Intravenous normal saline administered at 250ml/hr

Interventions

Intravenous normal saline administered at 250ml/hrDRUG

Intravenous normal saline administered at 250ml/hr

Also known as: Normal saline
Group 2 - Intervention Arm
Intravenous normal saline administered at 125ml/hrDRUG

Intravenous normal saline administered at 125ml/hr

Also known as: Normal saline
Group 1 - Placebo Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant
  • ≥ 18 years of age
  • Singleton gestation
  • Nulliparous
  • Vertex presentation
  • Gestational age ≥ 36 weeks
  • Bishop score ≤ 6
  • undergoing induction of labor

You may not qualify if:

  • Multiparous
  • Preeclampsia at admission
  • Gestational or chronic hypertension
  • Non-vertex presentation
  • Multiple gestation
  • Chorioamnionitis at admission
  • Intrauterine growth restriction (\<10th percentile)
  • BMI \> 50
  • Presence of uterine scar
  • Participation in any other research protocol involving induction of labor
  • Nonreassuring fetal heart rate tracing at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Vineet Shrivastava, MD

    Magella Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A power size calculation was performed using previously published institutional data as well as previously reported literature regarding induction of labor in nulliparous women. Baseline duration of labor induction among nulliparous women range from 21-30 hours. In order to obtain 80% power to detect a 20% decrease in the duration of labor at a statistical significance level of 0.05, 73 participants are needed in each group. In order to account for participant withdrawal and enrollment errors, the sample size is increased to 90 per group for a total of 180 participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 21, 2016

First Posted

December 12, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

US(1)