KetosisRARHYNCT01110005
A Trial of Intravenous Fluids During Labor
A study testing D5 Lactated Ringer's Solution (D5LR) and Lactated Ringer's Solution (LR) in people with Ketosis, run by Milton S. Hershey Medical Center at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ketosis
- What is being tested?
- D5 Lactated Ringer's Solution (D5LR) and Lactated Ringer's Solution (LR)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 17901
St. Luke Hospital
Bethlehem, Pennsylvania, 18015
The Penn State University
Hershey, Pennsylvania, 17033
The Reading Hospital and Medical Center
Reading, Pennsylvania, 19611
About this study
Official title: A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor
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.
Read the detailed description
This will be a multi-center, prospective, single-blind randomized trial of two types of IV fluids for maintenance hydration during labor. This study will be conducted at 4 sites: Reading (Reading Hospital), Allentown (Lehigh Valley), St. Luke Hospital and Hershey (Penn State College of Medicine). It will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery.
The primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. The primary outcome measure is the occurrence of a cesarean birth during the study period. The primary analysis will use an intent-to-treat approach to examine differences between the two IV fluid treatments in the proportion of deliveries requiring cesarean section.
- Conditions
- Ketosis
- Being tested
- D5 Lactated Ringer's Solution (D5LR), Lactated Ringer's Solution (LR)
- Keywords
- D5LR, glucose containing IV solution, LR, non glucose IV solution
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D5 Lactated Ringer's Solution (D5LR)Other
D5LR IV fluid
Lactated Ringer's Solution (LR)Other
LR IV fluid
| Study group | Role | What they receive |
|---|---|---|
| D5 Lactated Ringer's solution (D5LR) | Active comparator | IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. Receives: Other: D5 Lactated Ringer's Solution (D5LR) |
| Lactated Ringer's solution (LR) | Active comparator | Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr. Receives: Other: Lactated Ringer's Solution (LR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Section
Compare c-section rates between the D5LR and LR treatment groups
Measured: From onset of labor to delivery
Secondary outcomes (2)
Oxytocin Augmentation
Compare augmentation rates between the D5LR and LR treatment groups
Measured: From onset of labor to delivery
Time to Delivery
Compare time to delivery between the D5LR and LR treatment groups
Measured: From onset of labor to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KetosisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lehigh Valley Hospital, The Reading Hospital and Medical Center, St. Luke's Hospital, Pennsylvania
- Responsible party
- Principal investigator, Richard S. Legro, M.D., Milton S. Hershey Medical Center
- Investigators
- Richard S Legro, M.D., Study director, The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United StatesJohn Smulian, M.D., Principal investigator, Lehigh Valley Hospital, Allentown, Pennsylvania, United States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110005
- Sponsor's protocol ID
- 32118
- Acronym
- RARHY
- Status last verified
- Jan 2017
- First submitted
- 9 Apr 2010
- Last updated
- 19 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4.
PubMed 25758624
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Two-Arm, Single-Blind Randomized Trial of IV Fluids During Labor
- ClinicalTrials.gov ID
- NCT01110005
- Acronym / sponsor ID
- RARHY / 32118
- Conditions
- Ketosis
- Keywords
- D5LR, glucose containing IV solution, LR, non glucose IV solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Lehigh Valley Hospital, The Reading Hospital and Medical Center, St. Luke's Hospital, Pennsylvania
- Study start
- Apr 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Posted 14 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a multi-center, prospective, single-blind randomized trial of two types of IV fluids for maintenance hydration during labor. This study will be conducted at 4 sites: Reading (Reading Hospital), Allentown (Lehigh Valley), St. Luke Hospital and Hershey (Penn State College of Medicine). It will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery.
The primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. The primary outcome measure is the occurrence of a cesarean birth during the study period. The primary analysis will use an intent-to-treat approach to examine differences between the two IV fluid treatments in the proportion of deliveries requiring cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D5 Lactated Ringer's solution (D5LR) | Active comparator | Other: D5 Lactated Ringer's Solution (D5LR)IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. |
| Lactated Ringer's solution (LR) | Active comparator | Other: Lactated Ringer's Solution (LR)Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| D5 Lactated Ringer's Solution (D5LR)D5LR IV fluid | Other | D5 Lactated Ringer's solution (D5LR) |
| Lactated Ringer's Solution (LR)LR IV fluid | Other | Lactated Ringer's solution (LR) |
Primary outcome
C-Section
Time frame: From onset of labor to delivery
Compare c-section rates between the D5LR and LR treatment groups
2 secondary outcomes
Oxytocin Augmentation
Time frame: From onset of labor to delivery
Time to Delivery
Time frame: From onset of labor to delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25758624Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4.
- Individual participant dataSharing planned: No
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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.
Richard S Legro, M.D. study director
The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States
John Smulian, M.D. principal investigator
Lehigh Valley Hospital, Allentown, Pennsylvania, United States
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D5 Lactated Ringer's Solution (D5LR) and Lactated Ringer's Solution (LR) in people with Ketosis, run by Milton S. Hershey Medical Center at 4 sites 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 2 inclusion and 7 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 14 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
C-Section (time frame: From onset of labor to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01110005, which also lists 1 linked publication.
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 19 Jan 2024.