Labor; Forced or Induced, Affecting Fetus or NewbornEarly Phase 1NCT02989571
The Effects of Increased IV Hydration on Nulliparous Women Undergoing an Induction of Labor
A Early Phase 1 study testing Intravenous normal saline administered at 250ml/hr and Intravenous normal saline administered at 125ml/hr in people with Labor; Forced or Induced, Affecting Fetus or Newborn, run by MemorialCare Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor; Forced or Induced, Affecting Fetus or Newborn
- What is being tested?
- Intravenous normal saline administered at 250ml/hr and Intravenous normal saline administered at 125ml/hr
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Dec 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant
- ≥ 18 years of age
- Singleton gestation
- Nulliparous
- Vertex presentation
- Gestational age ≥ 36 weeks
- Bishop score ≤ 6
- undergoing induction of labor
Who cannot join
- Multiparous
- Preeclampsia at admission
- Gestational or chronic hypertension
- Non-vertex presentation
- Multiple gestation
- Chorioamnionitis at admission
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Beach Memorial Medical Center
Long Beach, California, 90806
About this study
Official title: A Double-Blinded Randomized Controlled Trial on the Effects of Increased Intravenous Hydration on Nulliparous Women Undergoing an Induction of Labor
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.
Read the detailed description
Exercise physiology has shown that increased fluid intake and replacement can improve skeletal muscle performance in prolonged exercise. Labor is a physically demanding process that is essentially an "exercise" of the uterus, where uterine contractions of varying strength and dilation lead to thinning and dilation of the cervix and to eventual delivery of the infant. It has logically been theorized that, as with any exercise, improved hydration and delivery of carbohydrates to uterine smooth muscle can help optimize the contractions needed during labor. Conversely, dehydration is believed to result not only in decreased uterine perfusion (due to decreased intravascular volume), but also in reduced delivery of nutrients and elimination of waste products from the contracting myometrium.
Inadequate maternal hydration has been postulated to be a contributing factor to prolonged or dysfunctional labor, in which uterine contractions are not sufficiently strong or are inappropriately coordinated to cause adequate cervical dilation and effacement. Even in patients who completely dilate, sufficient voluntary and involuntary muscle effort is required during the second stage of labor to achieve a vaginal delivery. Prolonged labors can not only lead to increased hospitalization cost, but also to increased risks of cesarean delivery for indications such as "failure to progress," chorioamnionitis (intrauterine infection), and postpartum hemorrhage. Establishing techniques to optimize the length and duration of labor has therefore been an area of particular research interest.
To date, several randomized, controlled studies have demonstrated that with higher intravenous (IV) fluid rates, there is a decreased frequency of prolonged labor and possibly a decreased need for oxytocin in patients who present in active labor. One of these studies was performed here at Long Beach Memorial by Garite et al under IRB approval and supervision. Importantly, a systematic review of these studies by the Cochrane Collaboration in 2013 demonstrated that increased intravenous fluid rates (250mL/hr vs 125mL/hr) appears to shorten the time to delivery and the cesarean delivery rate in patients who present in active labor.
The rate of induction of labor has increased dramatically in recent years, from 9.5% in 1990 to 22.1% in 2004. Women undergoing an induction of labor (whether elective or medically indicated) represent a distinct population from those who present in active labor, not only with regards to their baseline characteristics, but also with regards to their labor course and maternal and neonatal outcomes. There have been no studies thus far investigating the use of increased intravenous hydration in patients undergoing induction of labor, as previous studies have focused on patients who present in active labor. The objective of this study is therefore to determine the effect of increased intravenous hydration in nulliparous patients undergoing an induction of labor on length of labor, mode of delivery, and other maternal and neonatal outcomes.
- Being tested
- Intravenous normal saline administered at 250ml/hr, Intravenous normal saline administered at 125ml/hr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous normal saline administered at 250ml/hrDrug
Also called Normal saline
Intravenous normal saline administered at 250ml/hr
Intravenous normal saline administered at 125ml/hrDrug
Also called Normal saline
Intravenous normal saline administered at 125ml/hr
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Placebo Arm | Placebo comparator | Intravenous normal saline administered at 125ml/hr Receives: Drug: Intravenous normal saline administered at 125ml/hr |
| Group 2 - Intervention Arm | Active comparator | Intravenous normal saline administered at 250ml/hr Receives: Drug: Intravenous normal saline administered at 250ml/hr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of labor (hours of duration)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Secondary outcomes (11)
Epidural use (yes or no)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Oxytocin use (yes or no)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Mode of Delivery (vaginal delivery, operative vaginal delivery, or cesarean)
Measured via chart review
Measured: 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)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Maternal infectious or other morbidity (Yes or No)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Birth weight (numerical value in grams)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Neonatal weight at 72 hours of life (numerical value in grams)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
NICU admission (Yes or No)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Need for treatment of jaundice (yes or no)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
NICU length of stay (numerical value expressed in days)
Measured via chart review
Measured: within the first 7 days (plus or minus 3 days) after delivery
Delivery within 24 hours (yes or no)
Measured via chart review
Measured: within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor; Forced or Induced, Affecting Fetus or NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- MemorialCare Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vineet Shrivastava, MemorialCare Health System
- Investigators
- Vineet Shrivastava, MD, Principal investigator, Magella Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989571
- Sponsor's protocol ID
- 628-15
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2016
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded Randomized Controlled Trial on the Effects of Increased Intravenous Hydration on Nulliparous Women Undergoing an Induction of Labor
- ClinicalTrials.gov ID
- NCT02989571
- Acronym / sponsor ID
- 628-15
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- MemorialCare Health SystemUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Exercise physiology has shown that increased fluid intake and replacement can improve skeletal muscle performance in prolonged exercise. Labor is a physically demanding process that is essentially an "exercise" of the uterus, where uterine contractions of varying strength and dilation lead to thinning and dilation of the cervix and to eventual delivery of the infant. It has logically been theorized that, as with any exercise, improved hydration and delivery of carbohydrates to uterine smooth muscle can help optimize the contractions needed during labor. Conversely, dehydration is believed to result not only in decreased uterine perfusion (due to decreased intravascular volume), but also in reduced delivery of nutrients and elimination of waste products from the contracting myometrium.
Inadequate maternal hydration has been postulated to be a contributing factor to prolonged or dysfunctional labor, in which uterine contractions are not sufficiently strong or are inappropriately coordinated to cause adequate cervical dilation and effacement. Even in patients who completely dilate, sufficient voluntary and involuntary muscle effort is required during the second stage of labor to achieve a vaginal delivery. Prolonged labors can not only lead to increased hospitalization cost, but also to increased risks of cesarean delivery for indications such as "failure to progress," chorioamnionitis (intrauterine infection), and postpartum hemorrhage. Establishing techniques to optimize the length and duration of labor has therefore been an area of particular research interest.
To date, several randomized, controlled studies have demonstrated that with higher intravenous (IV) fluid rates, there is a decreased frequency of prolonged labor and possibly a decreased need for oxytocin in patients who present in active labor. One of these studies was performed here at Long Beach Memorial by Garite et al under IRB approval and supervision. Importantly, a systematic review of these studies by the Cochrane Collaboration in 2013 demonstrated that increased intravenous fluid rates (250mL/hr vs 125mL/hr) appears to shorten the time to delivery and the cesarean delivery rate in patients who present in active labor.
The rate of induction of labor has increased dramatically in recent years, from 9.5% in 1990 to 22.1% in 2004. Women undergoing an induction of labor (whether elective or medically indicated) represent a distinct population from those who present in active labor, not only with regards to their baseline characteristics, but also with regards to their labor course and maternal and neonatal outcomes. There have been no studies thus far investigating the use of increased intravenous hydration in patients undergoing induction of labor, as previous studies have focused on patients who present in active labor. The objective of this study is therefore to determine the effect of increased intravenous hydration in nulliparous patients undergoing an induction of labor on length of labor, mode of delivery, and other maternal and neonatal outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Placebo Arm | Placebo comparator | Drug: Intravenous normal saline administered at 125ml/hrIntravenous normal saline administered at 125ml/hr |
| Group 2 - Intervention Arm | Active comparator | Drug: Intravenous normal saline administered at 250ml/hrIntravenous normal saline administered at 250ml/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant
- ≥ 18 years of age
- Singleton gestation
- Nulliparous
- Vertex presentation
Key exclusion criteria (11 listed)
- Multiparous
- Preeclampsia at admission
- Gestational or chronic hypertension
- Non-vertex presentation
- Multiple gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous normal saline administered at 250ml/hrAlso: Normal salineIntravenous normal saline administered at 250ml/hr | Drug | Group 2 - Intervention Arm |
| Intravenous normal saline administered at 125ml/hrAlso: Normal salineIntravenous normal saline administered at 125ml/hr | Drug | Group 1 - Placebo Arm |
Primary outcome
Length of labor (hours of duration)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Measured via chart review
11 secondary outcomes
Epidural use (yes or no)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Oxytocin use (yes or no)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Mode of Delivery (vaginal delivery, operative vaginal delivery, or cesarean)
Time frame: 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)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Maternal infectious or other morbidity (Yes or No)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Birth weight (numerical value in grams)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Neonatal weight at 72 hours of life (numerical value in grams)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
NICU admission (Yes or No)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Need for treatment of jaundice (yes or no)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
NICU length of stay (numerical value expressed in days)
Time frame: within the first 7 days (plus or minus 3 days) after delivery
Delivery within 24 hours (yes or no)
Time frame: within 24 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vineet Shrivastava, MD principal investigator
Magella Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intravenous normal saline administered at 250ml/hr and Intravenous normal saline administered at 125ml/hr in people with Labor; Forced or Induced, Affecting Fetus or Newborn, run by MemorialCare Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of labor (hours of duration) (time frame: within the first 7 days (plus or minus 3 days) after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.