Induced LaborPhase 4NCT07124130
Lactated Ringer's and Dextrose 5% vs Only Lactated Ringer's in Labor
A Phase 4 study testing 5% Dextrose (D5) in Normal Saline (NS) and Lactate Ringer in people with Induced Labor, run by Eastern Virginia Medical School at 2 sites in 2 countries.
Trial summary
The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Induced Labor
- What is being tested?
- 5% Dextrose (D5) in Normal Saline (NS) and Lactate Ringer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2025to Mar 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nulliparous women
- Age 18 years or older and able to provide informed consent
- Singleton pregnancy at term
- Induction of labor
- Cephalic presentation
- Unfavorable cervix (Bishop score ≤ 6)
Who cannot join
- Age under 18 years
- Involuntarily confined or detained
- Considered as having diminished decision-making capacity
- Spontaneous labor (cervical exam between 5-6 cm) with or without ruptured membraned
- Favorable cervix (Bishop score >6)
- Diabetes mellitus (both gestational and pre-gestational)
Show all 13Show fewer
- Structural renal disease
- Acute or chronic kidney disease resulting in abnormal creatinine or proteinuria
- Evidence of chorioamnionitis or non-reassuring fetal testing at the time of enrollment
- Pyrexia (>38.0 degrees Celsius)
- Stillbirth
- Planned cesarean delivery
- Women presenting with emergent circumstances for labor induction
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Tetsuya Kawakita, MD, 757-446-7900, kawakit@odu.edu
About this study
Official title: Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes
The goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are:
- Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers?
- Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.
- Conditions
- Induced Labor
- Being tested
- 5% Dextrose (D5) in Normal Saline (NS), Lactate Ringer
- Keywords
- Induced labor, 5% dextrose, Lactated Ringers, duration of labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Dextrose (D5) in Normal Saline (NS)Drug
A solution of 5% dextrose and lactate ringer will be given to one group of participants.
Lactate RingerDrug
A Lactate Ringer solution will be given to one group of participants.
| Study group | Role | What they receive |
|---|---|---|
| 5% dextrose and Lactate Ringer | Active comparator | Participants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor. Receives: Drug: 5% Dextrose (D5) in Normal Saline (NS); Drug: Lactate Ringer |
| Lactate Ringer only | Active comparator | Participants randomized to this arm will receive an intravenous Lactate Ringer solution only. Receives: Drug: Lactate Ringer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from Induction Start To Delivery
Measured: From enrollment to the end of labor
Secondary outcomes (37)
Type of amniotomy
Spontaneous vs artificial
Measured: From enrollment until delivery
Mode of Delivery
The incidence of spontaneous vaginal delivery, operative vaginal delivery and cesarean delivery.
Measured: From enrollment until delivery.
Indication for cesarean delivery
Rate of failed induction of labor, arrest of active phase, arrest of descent, non-reassuring fetal condition, maternal request, other.
Measured: From enrollment until delivery.
Delivery within 12 hours of induction.
Incidence of delivery within 12 hours of induction.
Measured: Time from induction until delivery.
Delivery within 24 hours of Induction
Incidence of delivery within 24 hours of induction.
Measured: Time of induction to time of delivery.
Delivery within 36 hours of Induction
Incidence of delivery within 36 hours of induction.
Measured: From time of induction to time of delivery.
Delivery within 48 hours of Induction
Incidence of delivery within 48 hours of induction.
Measured: From time of induction to time of delivery.
Perineal Lacerations (Degree I-IV)
Degree of perineal lacerations occurring during delivery (first to fourth degree).
Measured: From time of enrollment to time of delivery.
Postpartum hemorrhage
Blood loss >1000 mL
Measured: Time of enrollment to time of delivery.
Blood Transfusion
Incidence of blood transfusions required during or after delivery.
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Isolated maternal fever
Incidence of maternal fever (T>38°C)
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Diagnosed Endometritis
The number of endometritis based on clinical signs and diagnostic tests.
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Wound Separation/Infection
Incidence of wound separation or infection requiring additional closure or antibiotics.
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Intraamniotic Infection
Presence of maternal fever, tachycardia, and/or fundal tenderness suggesting intraamniotic infection.
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Venous Thromboembolism (VTE)
Occurrence of venous thromboembolism.
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Hysterectomy
Occurrence of hysterectomy related to delivery complications.
Measured: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Intensive Care Unit (ICU) Admission
Admission to ICU for maternal complications.
Measured: From time of enrollment to ICU admission (up to 42 days post-delivery).
Maternal Death
Occurrence of maternal death during or after delivery.
Measured: From time of enrollment until maternal death (up to 42 days post-delivery).
Length of hospital stay
Days between admission and discharge
Measured: From time of hospital admission to time of hospital discharge (up to 50 days post-delivery).
Cord Prolapse
Occurrence of cord prolapse during labor.
Measured: From time of enrollment to delivery.
Use of Terbutaline
The number of terbutaline use for uterine contractions.
Measured: From time of enrollment to delivery.
Placement of Intrauterine Pressure Catheter
The number of placement of intrauterine pressure catheter during labor.
Measured: From time of enrollment to delivery.
Epidural Use
Use of epidural anesthesia during labor for pain relief.
Measured: From time of enrollment to delivery.
Neonatal Severe Respiratory Distress Syndrome (RDS)
Need for intubation and mechanical ventilation for ≥12 hours.
Measured: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal 5- minute Apgar score <7
Incidence of 5-minute Apgar score<7
Measured: From time of delivery up to 1 day following delivery.
Arterial umbilical cord pH <7
Incidence of arterial umbilical cord pH <7
Measured: From time of enrollment up to 1 day following delivery.
Neonatal outcome composite
Incidence of neonatal outcome composite
Measured: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Sepsis (Culture-proven or Presumed)
Incidence of neonatal sepsis, culture-proven or presumed.
Measured: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Intensive Care Unit (NICU) Admission
Admission of neonate to NICU.
Measured: From time of delivery to NICU admission. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Hypoxic-Ischemic Encephalopathy
Diagnosis of hypoxic-ischemic encephalopathy in neonates.
Measured: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Intraventricular Hemorrhage (Grade 3 or 4)
Occurrence of grade 3 or 4 intraventricular hemorrhage in neonates.
Measured: From time of enrollment to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Diagnosed Neonatal Necrotizing Enterocolitis
The number of diagnosis of necrotizing enterocolitis in the neonate.
Measured: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Head Cooling Therapy
Use of head cooling therapy for neonates to prevent brain injury.
Measured: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Blood Transfusion
Need for blood transfusion in the neonate.
Measured: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
NICU Stay >48 hours
Incidence of NICU stay lasting longer than 48 hours.
Measured: From NICU admission to NICU discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Length of Stay (days)
Total length of neonatal stay in the hospital.
Measured: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Bishop Score: Cervical Dilation, Effacement, Station, Position, Consistency
Baseline Bishop score (0-13, with 13 being more favorable to labor) and its changes during labor to assess cervical readiness for induction.
Measured: From time of enrollment to time of induction up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Induced LaborStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Responsible party
- Principal investigator, Tetsuya Kawakita, MD, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124130
- Sponsor's protocol ID
- 25-03-FB-0052
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Greenland S. Avoiding power loss associated with categorization and ordinal scores in dose-response and trend analysis. Epidemiology. 1995 Jul;6(4):450-4. doi: 10.1097/00001648-199507000-00025. No abstract available.
PubMed 7548361Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
PubMed 23303106Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand. 2010 Aug;89(8):1045-52. doi: 10.3109/00016349.2010.499447.
PubMed 20636243Gomez Slagle HB, Fonge YN, Caplan R, Pfeuti CK, Sciscione AC, Hoffman MK. Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6.
PubMed 35135684Berry M, Lamiman K, Slan MN, Zhang X, Arena Goncharov DD, Hwang YP, Rogers JA, Pacheco LD, Saade GR, Saad AF. Early vs delayed amniotomy following transcervical Foley balloon in the induction of labor: a randomized clinical trial. Am J Obstet Gynecol. 2024 May;230(5):567.e1-567.e11. doi: 10.1016/j.ajog.2024.01.028. Epub 2024 Feb 15.
PubMed 38367749Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
PubMed 20332509WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/
PubMed 30070803Shafaie FS, Mohaddesi H, Mirghafourvand M, Yulghunlu FA. A randomized, double-blinded, controlled trial comparing parenteral dextrose 5%, Ringer's solution and oral intake on the delivery outcomes in nulliparas. Int J Womens Health 2017;283-9.
Cowett RM, Susa JB, Giletti B, Oh W, Schwartz R. Glucose kinetics in infants of diabetic mothers. Am J Obstet Gynecol. 1983 Aug 1;146(7):781-6. doi: 10.1016/0002-9378(83)91077-3.
PubMed 6346883Dapuzzo-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 25758624Cerri V, Tarantini M, Zuliani G, Schena V, Redaelli C, Nicolini U. Intravenous glucose infusion in labor does not affect maternal and fetal acid-base balance. J Matern Fetal Med. 2000 Jul-Aug;9(4):204-8. doi: 10.1002/1520-6661(200007/08)9:43.0.CO;2-9.
PubMed 11048829Fisher AJ, Huddleston JF. Intrapartum maternal glucose infusion reduces umbilical cord acidemia. Am J Obstet Gynecol. 1997 Oct;177(4):765-9. doi: 10.1016/s0002-9378(97)70265-5.
PubMed 9369816Pare J, Pasquier JC, Lewin A, Fraser W, Bureau YA. Reduction of total labor length through the addition of parenteral dextrose solution in induction of labor in nulliparous: results of DEXTRONS prospective randomized controlled trial. Am J Obstet Gynecol. 2017 May;216(5):508.e1-508.e7. doi: 10.1016/j.ajog.2017.01.010. Epub 2017 Jan 30.
PubMed 28153654Philipson EH, Kalhan SC, Riha MM, Pimentel R. Effects of maternal glucose infusion on fetal acid-base status in human pregnancy. Am J Obstet Gynecol. 1987 Oct;157(4 Pt 1):866-73. doi: 10.1016/s0002-9378(87)80075-3.
PubMed 3314516Collinot H, Merrer J, Girault A, Goffinet F, Le Ray C. Implementation of glucose 5% supplementation protocol to reduce the duration of labor among women with cervical ripening by prostaglandins: The GLUCOSHORT before-and-after study. J Gynecol Obstet Hum Reprod. 2023 May;52(5):102558. doi: 10.1016/j.jogoh.2023.102558. Epub 2023 Feb 19.
PubMed 36806716
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Lactated Ringer's Plus Dextrose 5% vs Lactated Ringer's in Labor: A Randomized Control Trial on Maternal and Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT07124130
- Acronym / sponsor ID
- 25-03-FB-0052
- Conditions
- Induced Labor
- Keywords
- Induced labor, 5% dextrose, Lactated Ringers, duration of labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- 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 goal of this clinical trial is to determine which of two types of standard intravenous (IV) fluids (a combination of 5% dextrose and Lactated Ringers solution and Lactated Ringers solution alone) has a better influence on labor when inducing labor in pregnant women. The main questions it aims to answer are:
- Does the use of 5% dextrose and Lactated Ringers lead to a shorter labor than the use of just Lactated Ringers?
- Does the use of 5% dextrose and Lactated Ringers increase the risk of neonatal hypoglycemia when compared to Lactated Ringers? Participants in this trial will be randomly assigned to one of two groups: a group that receives a solution of 5% dextrose and Lactated Ringers, and a group that receives Lactated Ringers alone. Researchers will compare the outcomes of the two groups to see which IV fluid is more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% dextrose and Lactate Ringer | Active comparator | Drug: 5% Dextrose (D5) in Normal Saline (NS), Drug: Lactate RingerParticipants randomized to this arm will receive an intravenous solution of 5% dextrose and Lactate Ringer during labor. |
| Lactate Ringer only | Active comparator | Drug: Lactate RingerParticipants randomized to this arm will receive an intravenous Lactate Ringer solution only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nulliparous women
- Age 18 years or older and able to provide informed consent
- Singleton pregnancy at term
- Induction of labor
- Cephalic presentation
Key exclusion criteria (13 listed)
- Age under 18 years
- Involuntarily confined or detained
- Considered as having diminished decision-making capacity
- Spontaneous labor (cervical exam between 5-6 cm) with or without ruptured membraned
- Favorable cervix (Bishop score >6)
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 |
|---|---|---|
| 5% Dextrose (D5) in Normal Saline (NS)A solution of 5% dextrose and lactate ringer will be given to one group of participants. | Drug | 5% dextrose and Lactate Ringer |
| Lactate RingerA Lactate Ringer solution will be given to one group of participants. | Drug | 5% dextrose and Lactate Ringer, Lactate Ringer only |
Primary outcome
Time from Induction Start To Delivery
Time frame: From enrollment to the end of labor
37 secondary outcomes
Type of amniotomy
Time frame: From enrollment until delivery
Mode of Delivery
Time frame: From enrollment until delivery.
Indication for cesarean delivery
Time frame: From enrollment until delivery.
Delivery within 12 hours of induction.
Time frame: Time from induction until delivery.
Delivery within 24 hours of Induction
Time frame: Time of induction to time of delivery.
Delivery within 36 hours of Induction
Time frame: From time of induction to time of delivery.
Delivery within 48 hours of Induction
Time frame: From time of induction to time of delivery.
Perineal Lacerations (Degree I-IV)
Time frame: From time of enrollment to time of delivery.
Postpartum hemorrhage
Time frame: Time of enrollment to time of delivery.
Blood Transfusion
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Isolated maternal fever
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Diagnosed Endometritis
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Wound Separation/Infection
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Intraamniotic Infection
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Venous Thromboembolism (VTE)
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Hysterectomy
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery).
Intensive Care Unit (ICU) Admission
Time frame: From time of enrollment to ICU admission (up to 42 days post-delivery).
Maternal Death
Time frame: From time of enrollment until maternal death (up to 42 days post-delivery).
Length of hospital stay
Time frame: From time of hospital admission to time of hospital discharge (up to 50 days post-delivery).
Cord Prolapse
Time frame: From time of enrollment to delivery.
Use of Terbutaline
Time frame: From time of enrollment to delivery.
Placement of Intrauterine Pressure Catheter
Time frame: From time of enrollment to delivery.
Epidural Use
Time frame: From time of enrollment to delivery.
Neonatal Severe Respiratory Distress Syndrome (RDS)
Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal 5- minute Apgar score <7
Time frame: From time of delivery up to 1 day following delivery.
Arterial umbilical cord pH <7
Time frame: From time of enrollment up to 1 day following delivery.
Neonatal outcome composite
Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Sepsis (Culture-proven or Presumed)
Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Intensive Care Unit (NICU) Admission
Time frame: From time of delivery to NICU admission. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Hypoxic-Ischemic Encephalopathy
Time frame: From time of delivery to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Intraventricular Hemorrhage (Grade 3 or 4)
Time frame: From time of enrollment to hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Diagnosed Neonatal Necrotizing Enterocolitis
Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Head Cooling Therapy
Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Blood Transfusion
Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
NICU Stay >48 hours
Time frame: From NICU admission to NICU discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Neonatal Length of Stay (days)
Time frame: From time of delivery to time of hospital discharge. Includes the entire length of neonate's hospital stay, up to 1 year following delivery.
Bishop Score: Cervical Dilation, Effacement, Station, Position, Consistency
Time frame: From time of enrollment to time of induction up to 1 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 7548361Greenland S. Avoiding power loss associated with categorization and ordinal scores in dose-response and trend analysis. Epidemiology. 1995 Jul;6(4):450-4. doi: 10.1097/00001648-199507000-00025. No abstract available.
- Background: PubMed 23303106Carbone JF, Tuuli MG, Fogertey PJ, Roehl KA, Macones GA. Combination of Foley bulb and vaginal misoprostol compared with vaginal misoprostol alone for cervical ripening and labor induction: a randomized controlled trial. Obstet Gynecol. 2013 Feb;121(2 Pt 1):247-252. doi: 10.1097/AOG.0b013e31827e5dca.
- Background: PubMed 20636243Moraes Filho OB, Albuquerque RM, Cecatti JG. A randomized controlled trial comparing vaginal misoprostol versus Foley catheter plus oxytocin for labor induction. Acta Obstet Gynecol Scand. 2010 Aug;89(8):1045-52. doi: 10.3109/00016349.2010.499447.
- Background: PubMed 35135684Gomez Slagle HB, Fonge YN, Caplan R, Pfeuti CK, Sciscione AC, Hoffman MK. Early vs expectant artificial rupture of membranes following Foley catheter ripening: a randomized controlled trial. Am J Obstet Gynecol. 2022 May;226(5):724.e1-724.e9. doi: 10.1016/j.ajog.2021.11.1368. Epub 2022 Feb 6.
- Background: PubMed 38367749Berry M, Lamiman K, Slan MN, Zhang X, Arena Goncharov DD, Hwang YP, Rogers JA, Pacheco LD, Saade GR, Saad AF. Early vs delayed amniotomy following transcervical Foley balloon in the induction of labor: a randomized clinical trial. Am J Obstet Gynecol. 2024 May;230(5):567.e1-567.e11. doi: 10.1016/j.ajog.2024.01.028. Epub 2024 Feb 15.
- Background: PubMed 20332509Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- Background: PubMed 30070803WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/
- BackgroundShafaie FS, Mohaddesi H, Mirghafourvand M, Yulghunlu FA. A randomized, double-blinded, controlled trial comparing parenteral dextrose 5%, Ringer's solution and oral intake on the delivery outcomes in nulliparas. Int J Womens Health 2017;283-9.
- Background: PubMed 6346883Cowett RM, Susa JB, Giletti B, Oh W, Schwartz R. Glucose kinetics in infants of diabetic mothers. Am J Obstet Gynecol. 1983 Aug 1;146(7):781-6. doi: 10.1016/0002-9378(83)91077-3.
- Background: 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.
- Background: PubMed 11048829Cerri V, Tarantini M, Zuliani G, Schena V, Redaelli C, Nicolini U. Intravenous glucose infusion in labor does not affect maternal and fetal acid-base balance. J Matern Fetal Med. 2000 Jul-Aug;9(4):204-8. doi: 10.1002/1520-6661(200007/08)9:43.0.CO;2-9.
- Background: PubMed 9369816Fisher AJ, Huddleston JF. Intrapartum maternal glucose infusion reduces umbilical cord acidemia. Am J Obstet Gynecol. 1997 Oct;177(4):765-9. doi: 10.1016/s0002-9378(97)70265-5.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5% Dextrose (D5) in Normal Saline (NS) and Lactate Ringer in people with Induced Labor, run by Eastern Virginia Medical School at 2 sites in 2 countries.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tetsuya Kawakita, MD (757-446-7900, kawakit@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from Induction Start To Delivery (time frame: From enrollment to the end of labor). 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 NCT07124130, which also lists 27 linked publications.
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 22 Aug 2025.