PregnancyNCT01944787
Hydration and Rate of Cesarean Delivery Among Nulliparous
A study testing Routine and IV Hydration at 250cc hour in people with Pregnancy, run by Chauhan, Suneet P., M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Routine and IV Hydration at 250cc hour
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2018
- Phase
- Interventional
- 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 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
C A Combs MD PhD
Campbell, California, 95008
C A Combs, MD PhD, 408-371-7111 ext. 130, andrew_combs@obstsetrix.com
kimberly m mallory, RNC, 4087613565, kimberly_mallory@pediatrix.com
About this study
Official title: Intrapartum Hydration and Rate of Cesarean Delivery Among Nulliparous at > 37 Weeks: A Multicenter Randomized
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.
Read the detailed 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.
- Conditions
- Pregnancy
- Being tested
- Routine, IV Hydration at 250cc hour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoutineOther
IV Hydration at 125 cc hour
IV Hydration at 250cc hourOther
IV Hydration at 250 cc hour
| Study group | Role | What they receive |
|---|---|---|
| Routine | Active comparator | IV Hydration at 125 cc hour Receives: Other: Routine |
| Intervention | Experimental | IV Hydration at 250 cc hour Receives: Other: IV Hydration at 250cc hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 Years
Secondary outcomes (1)
labor
The secondary objectives of this randomized trial are to compare the 2 groups regarding:
Time from randomization to delivery (minutes)
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 670 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chauhan, Suneet P., M.D.
- Responsible party
- Sponsor
- Investigators
- Suneet P Chauhan, MD, Principal investigatorAndrew Combs, MD PhD, Principal investigator, Obstetrix Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944787
- Sponsor's protocol ID
- 12-05-SP-50
- Status last verified
- Sep 2013
- First submitted
- 6 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Hydration and Rate of Cesarean Delivery Among Nulliparous at > 37 Weeks: A Multicenter Randomized
- ClinicalTrials.gov ID
- NCT01944787
- Acronym / sponsor ID
- 12-05-SP-50
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 670 participants (estimated)
- Lead sponsor
- Chauhan, Suneet P., M.D.
- Study start
- Sep 2013
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 18 Sep 2013 (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 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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine | Active comparator | Other: RoutineIV Hydration at 125 cc hour |
| Intervention | Experimental | Other: IV Hydration at 250cc hourIV Hydration at 250 cc hour |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| RoutineIV Hydration at 125 cc hour | Other | Routine |
| IV Hydration at 250cc hourIV Hydration at 250 cc hour | Other | Intervention |
Primary outcome
rate of cesarean section
Time frame: 5 Years
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.
1 secondary outcome
labor
Time frame: 5 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
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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.
Suneet P Chauhan, MD principal investigator
Andrew Combs, MD PhD principal investigator
Obstetrix Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine and IV Hydration at 250cc hour in people with Pregnancy, run by Chauhan, Suneet P., M.D. 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Sep 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suneet Chauhan, MD (757-672-5955, mfmchauhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of cesarean section (time frame: 5 Years). 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 18 Sep 2013.