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| Name | Class |
|---|---|
| University of Modena and Reggio Emilia | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Lactate Ringer only | Active Comparator | Participants randomized to this arm will receive an intravenous Lactate Ringer solution only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% Dextrose (D5) in Normal Saline (NS) | Drug | A solution of 5% dextrose and lactate ringer will be given to one group of participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from Induction Start To Delivery | From enrollment to the end of labor |
| Measure | Description | Time Frame |
|---|---|---|
| Type of amniotomy | Spontaneous vs artificial | From enrollment until delivery |
| Mode of Delivery | The incidence of spontaneous vaginal delivery, operative vaginal delivery and cesarean delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tetsuya Kawakita, MD | Contact | 757-446-7900 | kawakit@odu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7548361 | Background | 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. | |
| 23303106 | Background | Carbone 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2025 | Jul 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 19, 2025 | Jul 18, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D000077324 |
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| Lactate Ringer | Drug | A Lactate Ringer solution will be given to one group of participants. |
|
| 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. | From enrollment until delivery. |
| Delivery within 12 hours of induction. | Incidence of delivery within 12 hours of induction. | Time from induction until delivery. |
| Delivery within 24 hours of Induction | Incidence of delivery within 24 hours of induction. | Time of induction to time of delivery. |
| Delivery within 36 hours of Induction | Incidence of delivery within 36 hours of induction. | From time of induction to time of delivery. |
| Delivery within 48 hours of Induction | Incidence of delivery within 48 hours of induction. | From time of induction to time of delivery. |
| Perineal Lacerations (Degree I-IV) | Degree of perineal lacerations occurring during delivery (first to fourth degree). | From time of enrollment to time of delivery. |
| Postpartum hemorrhage | Blood loss >1000 mL | Time of enrollment to time of delivery. |
| Blood Transfusion | Incidence of blood transfusions required during or after delivery. | From time of enrollment to hospital discharge (up to 42 days post-delivery). |
| Isolated maternal fever | Incidence of maternal fever (T>38°C) | 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. | 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. | 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. | From time of enrollment to hospital discharge (up to 42 days post-delivery). |
| Venous Thromboembolism (VTE) | Occurrence of venous thromboembolism. | From time of enrollment to hospital discharge (up to 42 days post-delivery). |
| Hysterectomy | Occurrence of hysterectomy related to delivery complications. | From time of enrollment to hospital discharge (up to 42 days post-delivery). |
| Intensive Care Unit (ICU) Admission | Admission to ICU for maternal complications. | From time of enrollment to ICU admission (up to 42 days post-delivery). |
| Maternal Death | Occurrence of maternal death during or after delivery. | From time of enrollment until maternal death (up to 42 days post-delivery). |
| Length of hospital stay | Days between admission and discharge | From time of hospital admission to time of hospital discharge (up to 50 days post-delivery). |
| Cord Prolapse | Occurrence of cord prolapse during labor. | From time of enrollment to delivery. |
| Use of Terbutaline | The number of terbutaline use for uterine contractions. | From time of enrollment to delivery. |
| Placement of Intrauterine Pressure Catheter | The number of placement of intrauterine pressure catheter during labor. | From time of enrollment to delivery. |
| Epidural Use | Use of epidural anesthesia during labor for pain relief. | From time of enrollment to delivery. |
| Neonatal Severe Respiratory Distress Syndrome (RDS) | Need for intubation and mechanical ventilation for ≥12 hours. | 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 | From time of delivery up to 1 day following delivery. |
| Arterial umbilical cord pH <7 | Incidence of arterial umbilical cord pH <7 | From time of enrollment up to 1 day following delivery. |
| Neonatal outcome composite | Incidence of neonatal outcome composite | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From time of enrollment to time of induction up to 1 week. |
| Policlinico di Modena | Recruiting | Modena | Italy |
| 20636243 | Background | Moraes 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. |
| 35135684 | Background | Gomez 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. |
| 38367749 | Background | Berry 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. |
| 20332509 | Background | Schulz 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. |
| 30070803 | Background | WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/ |
| Background | Shafaie 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. |
| 6346883 | Background | 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. |
| 25758624 | Background | 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. |
| 11048829 | Background | Cerri 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. |
| 9369816 | Background | Fisher 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. |
| 28153654 | Background | Pare 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. |
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| 22865033 | Background | Sharma C, Kalra J, Bagga R, Kumar P. A randomized controlled trial comparing parenteral normal saline with and without 5% dextrose on the course of labor in nulliparous women. Arch Gynecol Obstet. 2012 Dec;286(6):1425-30. doi: 10.1007/s00404-012-2485-1. Epub 2012 Aug 4. |
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| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |