[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"labor-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:labor-complication":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,42,76,100,127,156,179,205],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100553645","phase-2-antibiotic-prophylaxis-to-prevent-obesity-related-induction-complications-in-nulliparae-at-term-20-100553645",false,"NCT06488781","Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0","Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 (APPOINT 2.0): A Multi-center Randomized Controlled Trial","Inclusion Criteria:\n\n* BMI ≥30\n* No prior deliveries at or beyond 20 weeks gestation\n* Undergoing induction of labor\n* Gestational age 37 weeks or more\n* Age 15-45\n* Not receiving IAP for GBS prophylaxis\n\nExclusion Criteria:\n\n* Fetal death prior to labor induction\n* Known fetal anomaly\n* Multiple gestation\n* Ruptured membranes for more than 12 hours\n* Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction\n* Previous myometrial surgery\n* Allergy to azithromycin or beta-lactam antibiotics","FEMALE","15 Years","45 Years",{"count":20,"type":21},787,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to have comorbidities that would necessitate delivery prior to their due date (i.e. prior to 40 weeks gestation), and class III obesity specifically is an indication for delivery by 39 weeks, these patients have a high rate of labor induction. In nulliparous women from the general population (obese and non-obese), labor induction at 39 weeks (compared to expectant management) is associated with less maternal morbidity and a lower cesarean rate. Researchers previously conducted a pilot randomized placebo-controlled trial in obese, nulliparous women undergoing labor induction at term and found that the cesarean delivery rate was lower in women who received a prophylactic antibiotic regimen during labor compared with those who received the placebo. Researchers proposed multi-center trial aims to test this hypothesis in a large sample with adequate power to determine whether prophylactic antibiotics during labor are associated with a decrease in the rate of cesarean delivery in term, nulliparous, obese women. If the findings from the pilot trial are confirmed, this would represent a novel intervention to decrease the cesarean delivery rate in a subset of women at highest risk for cesarean-related complications.",[27,28],"Obesity in Pregnancy","Labor Complication","RECRUITING","2026-03-10",{"date":32,"type":33},"2026-03-12","ACTUAL",{"date":35,"type":33},"2025-04-29",{"date":37,"type":21},"2028-12",{"name":39,"class":40},"University of Oklahoma","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":41},"100552338","inertial-sensors-for-obstetrical-walking-epidural-tracking-100552338","NCT06471790","Inertial Sensors for Obstetrical Walking Epidural Tracking","Movement Observation and Tracking In Obstetrics - Epidural and Ambulation Feasibility Study Using Inertial Sensors","MOTION-EASE","Inclusion Criteria:\n\n* pregnancy \\>= 38 gestation weeks\n* no significant medical history (American Society of Anesthesiologists class ASA 1)\n* receiving low-dose epidural analgesia with ambulation (in accordance with current service protocol)\n* not opposed to the study\n\nExclusion Criteria:\n\n* Refusal to participate in this study\n* Non-French-speaking patient\n* History of osteoarticular pathology likely to change gate (severe scoliosis, spinal surgery, congenital hip deformity, pelvic fracture, ligament or knee joint pathology)\n* adults under legal protection\n* multiple pregnancy\n* need for continuous intravenous infusion with infusion stand during ambulation","18 Years","40 Years",{"count":53,"type":21},30,"OBSERVATIONAL","Freedom of movement and the ability to walk are crucial during the first stage of labor, potentially reducing labor duration, cesarean section risk, epidural analgesia use, and bladder catheterization. While the clinical effects of ambulation during labor remain controversial, there is a consensus on its positive impact on the birthing experience and satisfaction.\n\nEpidural analgesia remains the gold standard for pain control during labor, with a utilization rate of 82% in France. Recent advancements in obstetric analgesia have allowed for lower doses of analgesics, often administered via patient-controlled analgesia, which maintains the potential for ambulation during labor. However, only a small number of maternity units in France offer this technique. The main barriers include organizational issues such as unsuitable facilities, lack of wireless telemetry, and potential risks such as falls and hypotension.\n\nSignificant changes in gait characteristics are observed throughout pregnancy, particularly during the third trimester, and are studied in laboratory settings using video capture and analysis. Gait during labor is influenced by pain, fetal progression, and anatomical changes in the pelvis. The presence of epidural analgesia, where local anesthetics likely affect neural transmission, may impact motor commands and sensory feedback, further altering gait characteristics. These biomechanical aspects of labor remain understudied.\n\nWearable inertial sensors show promise in maternal health monitoring by providing real-time data for motion and gait studies. However, their application has not been described or validated during labor, particularly in walking conditions. Continuous dynamic study of gait in these conditions could enable non-invasive, non-intrusive monitoring of analgesia effectiveness, fall risk prediction, and labor progression analysis.\n\nThe aim of this feasibility study is to validate the use of wearable inertial sensors to quantify movements and characterize gait during the first stage of labor, both with and without low-dose epidural analgesia.",[57,58,28],"Pregnancy Related","Epidural; Anesthesia, Headache",[60,61,62,63,64,65,66],"PREGNANCY","LABOR","EPIDURAL ANALGESIA","WALKING EPIDURAL","MOVEMENTS","GAIT","INERTIAL SENSOR","2026-01-16",{"date":69,"type":33},"2026-01-20",{"date":71,"type":33},"2024-11-11",{"date":73,"type":21},"2026-07-12",{"name":75,"class":40},"Hospices Civils de Lyon",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":41},"100385822","the-role-of-oxytocin-in-the-second-stage-of-labor-100385822","NCT04303702","The Role of Oxytocin in the Second Stage of Labor","Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)","ROSSoL","Inclusion Criteria:\n\n* Nulliparous pregnant women \\>\u002F= 37 weeks gestation\n* Singleton pregnancies\n* Admission for induction of labor or spontaneous labor\n\nExclusion Criteria:\n\n* Multiple gestations\n* Multiparous patients\n* Patients with major fetal anomalies\n* Not on oxytocin at the time of complete cervical dilation\n* Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation\n* Maternal medical condition that prohibits prolonged second stage",true,{"count":86,"type":21},400,[88],"NA","This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.",[28],"2025-12-29",{"date":93,"type":33},"2026-01-05",{"date":95,"type":33},"2022-07-01",{"date":97,"type":21},"2027-09-30",{"name":99,"class":40},"Washington University School of Medicine",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":84,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":41},"100506995","early-diagnosis-and-intervention-for-fetal-malposition-in-active-labor-and-its-impact-on-mode-of-delivery-100506995","NCT05881629","Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery","Early Diagnosis and Intervention for Fetal Malposition in Active Labor and Its Impact on Mode of Delivery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Maternal age \\>18\n* Term gestation (\\>37 weeks)\n* Singleton pregnancy\n* Spontaneous or induced active labor (cervical dilation 6-9cm)\n* Epidural anesthesia\n* Cephalic fetal presentation, OP\u002FOT position diagnosed by bedside ultrasound\n* Continuous external fetal monitoring\n* Ability to consent\n\nExclusion Criteria:\n\n* Multiple gestations\n* Unanesthetized labor\n* Known fetal anomalies\n* Known intrauterine fetal demise\n* Inability to consent",{"count":108,"type":21},200,[88],"The goal of this randomized trial is to test if changing a person's position in labor can increase the chances of delivering their baby vaginally.\n\nSpecifically, it aims to answer the questions:\n\n* In fetuses who are facing upwards (occiput posterior, OP) or sideways (occiput transverse, OT) during labor, does changing the patient's position during active labor to a side-lying posture with a peanut ball increase the chances of them having a successful, spontaneous vaginal delivery?\n* Does changing the patient's position in active labor affect the position of the baby at the time of delivery?\n* Do intentional position changes in labor impact patient-perceived autonomy during their labor and delivery experience?\n\nParticipants will:\n\n* Receive an ultrasound during labor to determine the position of their baby\n* Be asked to adopt a specific position in labor (side-lying with peanut ball) if they are randomized to the study group\n* Receive additional ultrasounds during labor to assess their baby's position\n* Fill out a questionnaire about their labor experience following the delivery of their baby",[112,113,28],"Cesarean Delivery Affecting Fetus","Labor Dystocia",[115,116,117],"fetal malposition","occiput posterior","occiput transverse","2025-09-03",{"date":120,"type":33},"2025-09-11",{"date":122,"type":33},"2024-05-01",{"date":124,"type":21},"2026-09-01",{"name":126,"class":40},"Women and Infants Hospital of Rhode Island",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":84,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100500082","the-norwegian-world-health-organisation-labour-care-guide-trial-norwel-100500082","NCT05791630","The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)","The Norwegian World Health Organisation Labour Care Guide Trial","NORWEL","Inclusion Criteria:\n\n* Women in active labour\n* Labour and delivery at study sites\n\nExclusion Criteria:\n\n* None",{"count":136,"type":21},23650,[88],"Appropriate and timely care during birth is critical to the survival and health of women and their babies. In 2020, the World Health Organization (WHO) presented the Labour Care Guide (LCG) as the new recommended tool for monitoring birth and assessing progression, replacing the WHO partograph. This evidence-based guide was designed to ensure improved quality and safety of care, and to avoid unnecessary interventions during birth. The LCG was developed to be used in all settings globally, but it has only been tested in health facilities in South America, Asia and Africa, while it has not been tested in high-income settings. Implementing a new guideline for monitoring birth is a comprehensive operation that will affect both the national economy, health systems, and individual patients; therefore, further research on the possible advantages is needed before national enrolment. Hence, the trial proposed in this application is crucial to form the required foundation of knowledge. The trial will be conducted in labour wards at ten hospitals, covering all health regions in Norway, and the established Norwegian Research Network for Clinical Studies in Obstetrics (NORBIRTH), with dedicated local principal investigators, will provide a robust research environment. This trial will test the effect of the LCG. Results from this trial will provide knowledge needed to determine a future implementation of the LCG in Norway.",[113,28,140,141,142,143,144,145],"Labor Onset and Length Abnormalities","Labor (Obstetrics)--Complications","Experience, Life","Progression","Cesarean Section Complications","Apgar; 4-7 at 1 Minute","2025-04-02",{"date":148,"type":33},"2025-04-04",{"date":150,"type":33},"2025-04-01",{"date":152,"type":21},"2030-12-31",{"name":154,"class":40},"Ostfold Hospital Trust",10,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":22,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":169,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":41},"100553086","fri-a-method-of-reading-cardiotocography-ctg-in-labor-100553086","NCT06481514","FRI a Method of Reading Cardiotocography (CTG) in Labor","Fetal Reserve Index (FRI) as a Tool for Improving Surveillance Cardiotocography in Labor.","FINIS","Inclusion Criteria:\n\n* Women in the active phase of labor who presented when they entered the room I delivered a negative admission test (i.e. a normoreactive CTG according to ACOG) and that subsequently present during labor a diagnosis of category II CTG\n* Single term pregnancy\n* Signature of informed consent\n\nExclusion criteria\n\n* Failure to sign the informed consent\n* Previous caesarean section (TOLAC)\n* Twin pregnancy\n* Gestational age \\\u003C37 weeks\n* Known genetic\u002Fchromosomal syndromes and\u002For malformations, excluding heart disease without contraindication to vaginal birth\n\nExclusion Criteria:\n\n\\-",{"count":165,"type":21},290,[88],"The objective of the study is to investigate the FRI's ability to identify cases requiring urgent intervention which will present an adverse perinatal outcome (respiratory acidosis, metabolic acidosis, Apgar index, etc.) compared to the classical interpretation of CTG.\n\nPatients whose CTG in labor will be considered non-reassuring will be enrolled and randomized into two groups. The \"Fetal Reserve Index\" algorithm will be applied to the first group of patients.\n\nThe second group of patients will, however, be managed according to the usual protocols internal management.",[28],"NOT_YET_RECRUITING","2024-06-25",{"date":172,"type":33},"2024-07-01",{"date":174,"type":21},"2024-07",{"date":176,"type":21},"2025-12",{"name":178,"class":40},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":84,"sex":16,"minAge":50,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100494537","phase-3-saint-safe-induction-of-labor-trial-100494537","NCT05719467","SAINT: Safe Induction of Labor Trial","A Double-blind Randomized Placebo-controlled Four-arm Trial to Assess the Efficacy of Oral Bicarbonate and Intravenous Butylscopolamine Bromide to Facilitate Spontaneous (Non-operative) Delivery in Pregnant Female Participants With Induction of Labor","SAINT","Inclusion Criteria:\n\n1. Participant must be between 18 and 50 years of age at the time of signing the informed consent.\n2. Participants who are female, pregnant, nulliparous and at or above 37 weeks of gestation\n3. Participants who fulfill hospital criteria for induction of labor, and where a decision to induce labor has been made\n4. Participants carrying a fetus in vertex position\n5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Elective cesarean section\n3. Spontaneous start of labor\n4. Known maternal intestinal stenosis, ileus or megacolon\n5. Persisting maternal tachycardia (heart rate \\> 130 beats per minute) \\>30 minutes continuously.\n6. Known maternal myasthenia gravis\n7. Persisting fetal tachycardia (fetal heart rate baseline \\> 170 beats per minute) \\>30 minutes continuously.\n8. Maternal hypersensitivity to any of the ingredients in IMP (butylscopolamine bromide, bicarbonate or sodium chloride)\n9. Women with heart disease who are under surveillance with heart rate monitoring during labor\n10. Known fetal heart disease or known fetal malformations in the gastrointestinal system\n11. Untreated maternal glaucoma\n12. Maternal electrolyte disturbance: severe hyponatremia, severe hypokalemia\n13. Maternal moderate\u002Fsevere kidney failure (stage III-V: glomerulus filtration rate \\\u003C59 ml\u002Fminute\u002F1.73m2 )\n14. Maternal elevated serum creatinine (\\>90umol\u002FL)\n15. Maternal elevated Alanine Aminotransferase (ALAT) \\>100 U\u002FL. Participation can still be considered for participants with ALAT \\>100 U\u002FL if explained by obstetric cholestasis or HELLP syndrome.","50 Years",{"count":189,"type":21},3000,[191],"PHASE3","Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy.\n\nAt the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH \\\u003C 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery.\n\nGiven that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted.\n\nBicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events.\n\nThe rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.",[28,194,57],"Induced; Birth","2024-04-02",{"date":197,"type":33},"2024-04-04",{"date":199,"type":33},"2023-01-03",{"date":201,"type":21},"2027-12-31",{"name":203,"class":40},"Oslo University Hospital",5,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":84,"sex":16,"minAge":50,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":22,"phases":215,"briefSummary":216,"conditions":217,"keywords":218,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":41},"100536198","intrapartum-ultrasound-in-labor-sonography-only-few-internal-examinations-100536198","NCT06261710","Intrapartum Ultrasound in Labor: Sonography Only, Few Internal Examinations","SOFIE","Inclusion Criteria:\n\n* Pregnant women of at least 18 years of age with a singleton in the cephalic position\n* Spontaneous onset of labor; births after induction of labor with otherwise suitable inclusion and exclusion criteria are also permitted.\n\nExclusion Criteria:\n\n* Emergency situations such as maternal or fetal bleeding\n* Indication for urgent delivery by caesarean section\n* Pathological cardiotocogram\n* non-cephalic positions\n* under 18 years of age\n* women giving birth who are unable to give consent","60 Years",{"count":214,"type":21},356,[88],"This is a prospective, randomized trial to determine whether the use of sonographic parameters during labor results in less intrapartum infection compared to traditional invasive examination. Other secondary outcomes include maternal satisfaction and overall birth outcomes.",[28],[219,220],"Chorioamnionitis","Sonography","2024-02-14",{"date":223,"type":33},"2024-02-16",{"date":225,"type":21},"2024-02-27",{"date":227,"type":21},"2030-02-01",{"name":229,"class":40},"Larry Hinkson"]