Current RCTs (in progress/not yet published): reduction of cesarean

Last updated June 13, 2012

ClinicalTrials.gov: Current or pending RCTs

Study Title: Reduction of Cesareans by Nitric Oxide (NO) Donors in Post Term Pregnancies

Conditions: Prolonged Pregnancy; “Nulliparity”

Interventions: Drug: IMN; Drug: Placebo

Sponsor: Assistance Publique - Hôpitaux de Paris

Study Design: Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment

NCT Number: NCT00930618

Completion Date: June 2012

Last Updated Date: April 7, 2011

Outcome Measures: Number of cesarean sections; Number of labor inductions; Number of spontaneous labors; Cesarean for failed labor induction; Cesarean for FHR abnormalities; Cesarean for arrested labor; Bishop score at 41+2, 41+4, and labor induction; Isosorbide mononitrate adverse effects; Maternal satisfaction; Neonatal morbidity

Study Title: Fetal ST Segment and T Wave Analysis in Labor

Conditions: Pregnancy; Obstetric Labor; Parturition

Intervention: Device: fetal STAN monitor

Sponsors: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Neoventa Medical

Study Design: Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention

NCT Number: NCT01131260

Completion Date: June 2012

Last Updated Date: April 20, 2011

Outcome Measures: Intrapartum fetal death; Neonatal Death; Apgar score <= 3 at 5 minutes; Neonatal seizure; Cord artery pH <= 7.05 and base deficit >= 12 mmol/L; Intubation for ventilation at delivery; Presence of neonatal encephalopathy; Cesarean delivery; Indication for cesarean delivery; Forceps or vacuum delivery; Chorioamnionitis; Postpartum hemorrhage; Postpartum endometritis; Duration of labor post-randomization; Length of hospital stay; Maternal heart rate; Maternal blood pressure; Maternal oxygen saturation; Neonatal death; Apgar score at 5 minutes; Umbilical arterial blood gases; Need for chest compression or intubation for ventilation in the delivery room; Special care nursery admission (anything more than well-baby nursery); Seizure; ST events; Shoulder dystocia

Study Title: Fit For Delivery: A Study of the Effect of Exercise Sessions and Nutritional Counselling on Pregnancy Outcome

Conditions: Pregnancy; Obesity; Diabetes

Intervention: Behavioral: Nutritional counseling and twice weekly exercise groups

Sponsor: Sorlandet Hospital HF

Study Design: Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Investigator); Primary Purpose: Prevention

NCT Number: NCT01001689

Completion Date: November 2013

Last Updated Date: December 20, 2011

Outcome Measures: Maternal weight gain in pregnancy; Weight of the newborn; Maternal serum glucose level, measured fasting and after a 2 hour glucose challenge test; Maternal weight retention; Measurement of serum levels of hormones which regulate serum glucose levels, in both the pregnant woman and her newborn baby.; Incidence of operative vaginal delivery and Cesarean section

Study Title: Metformin in Obese Non-diabetic Pregnant Women

Conditions: Pregnancy Complications; Obesity

Interventions: Drug: Metformin; Drug: Placebo

Sponsors: Epsom and St Helier University Hospitals NHS Trust; Fetal Medicine Foundation; King's College Hospital NHS Trust

Study Design: Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Prevention

NCT Number: NCT01273584

Completion Date: September 2014

Last Updated Date: January 31, 2012

Outcome Measures: Birth Weight centile (z-score); Maternal Weight gain; Development of Gestational Diabetes; Development of hypertension/Preeclampsia; Caesarian Section; Postpartum haemorrhage; Neonatal Hypoglycemia; Prematurity; Hyperbilirubinemia; Polycythaemia; Respiratory Distress; Macrosomia/Large for Gestational Age; Birth Trauma; Apgar score <6; Admission to level 2 or greater neonatal unit; Stillbirth/Intrauterine deaths; 2nd trimester miscarriages

Study Title: Accelerated Titration of Oxytocin for Nulliparous Patients With Labour Dystocia: ACTION Pilot Study

Condition: Labour Dystocia

Intervention: Drug: Oxytocin

Sponsors: Ottawa Hospital Research Institute; The Physicians' Services Incorporated Foundation; The Ottawa Hospital; Canadian Institutes of Health Research (CIHR); Sainte Justine Hospital Research Institute

Study Design: Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment

NCT Number: NCT01397630

Completion Date: September 2013

Last Updated Date: July 18, 2011

Outcome Measures: Consent Rate; Protocol Violation Rate; Maternal satisfaction; Caesarean section rate; Rate of Maternal and Fetal/Neonatal Adverse Events

Study Title: High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour

Condition: Birth; Delayed

Intervention: Drug: Syntocinon

Sponsor/Collaborators: Göteborg University; Sahlgrenska University Hospital, Sweden; NU Hospital Group

Study Design: Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);

NCT Number: NCT01587625

Completion Date: December 2015

Last Updated Date: April 27, 2012

Study Title: Patient Satisfaction of Cervical Ripening in an Outpatient Setting

Condition: Pregnancy

Interventions: Other: Patient discharged home after foley bulb placement.; Other: Inpatient

Sponsor: Cedars-Sinai Medical Center

Study Design: Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment

NCT Number: NCT01605474

Completion Date: NR

Last Updated Date: May 23, 2012

NIH Reporter: RCTs

Project Number: 5R01HD058061-03 Contact PI / Project Leader: STEVENS, VICTOR J

Title: WEIGHT MANAGEMENT FOR IMPROVED PREGNANCY OUTCOMES

Awardee Organization: KAISER FOUNDATION RESEARCH INSTITUTE

Abstract Text: DESCRIPTION (provided by applicant): Historically, under nutrition has been a major health concern. Recently however, over nutrition has also become a serious public health problem in the United States and other industrialized countries. With the new obesity epidemic we see increasing morbidity, mortality, and public health burden, particularly among reproductive-aged women. Whereas morbid obesity was once rare among pregnant women, a rapidly increasing proportion of obstetrics patients now have levels of obesity which dramatically increase their risk of serious pregnancy complications. These complications include increased risk of miscarriage, stillbirth, having a fetus that is too large leading to cesarean section or birth injuries for mom and baby from vaginal delivery, and death of the infant in the newborn period. More than 1/3 of women in the U.S. are now starting their pregnancies with a body mass index or 30 or greater, a condition that was unusual to rare 50 years ago. Given the serious consequences of added weight gain during pregnancy for obese women, such as gestational diabetes, pre-eclampsia, or cesarean delivery, the best strategy during their pregnancy may be to maintain a steady weight rather than gaining 15 pounds or more. Unfortunately, there is little research on the efficacy and feasibility of minimizing weight gain during pregnancy. This study is designed to address that problem. Two hundred women with BMIs of 30 or greater at the start of their pregnancy will be recruited for this feasibility test. All participants will be members of a nonprofit managed care organization that provides high-quality obstetrics care. Patients who volunteer to participate will be randomly assigned to either a weight maintenance intervention or to usual care. Participants assigned to the intervention will participate in a weight maintenance program designed to help them eat a nutritionally balanced diet and to also control energy intake to minimize weight gain during their pregnancy. Participants (and their babies) in both groups will participate in follow- up assessments at 2 weeks postpartum, 6 months postpartum and one year postpartum. The primary outcome measures will be mothers' weight gain during pregnancy, the amount of weight retained after delivery, and the proportion of large for gestational age infants. Secondary outcomes will include multiple safety measures of the mothers and their babies. In addition to measures of safety, our secondary analyses will address the feasibility and acceptability of a weight management intervention among obese pregnant women. PUBLIC HEALTH RELEVANCE: Obesity and excessive weight gain during pregnancy lead to increased risks of high blood pressure, gestational diabetes, large infants, and cesarean section. This study will test an intensive, weight management program for obese pregnant women to prevent too much weight gain and reduce risk of pregnancy complications. Given that pregnancy is one of the primary reasons women seek medical care, interventions that prevent excessive weight gain during pregnancy could have significant public health impact by preventing worsening obesity and its long-term effects on mothers and their babies.

Public Health Relevance Statement:

PROJECT NARRATIVE: Obesity and excessive weight gain during pregnancy lead to increased risks of high blood pressure, gestational diabetes, large infants, and cesarean section. This study will test an intensive, weight management program for obese pregnant women to prevent too much weight gain and reduce risk of pregnancy complications. Given that pregnancy is one of the primary reasons women seek medical care, interventions that prevent excessive weight gain during pregnancy could have significant public health impact by preventing worsening obesity and its long-term effects on mothers and their babies.

Project Start Date: 12-MAY-2009

Project End Date: 30-APR-2013

Administering Institutes or Centers: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

NIH Reporter: other studies of potential interest

Project Number: 1G13LM010878-01 Contact PI / Project Leader: WOLF, JACQUELINE HELENE

Title: A SOCIAL HISTORY OF CESAREAN SECTION IN THE UNITED STATES

Awardee Organization: OHIO UNIVERSITY ATHENS

Abstract Text: DESCRIPTION (provided by applicant): Between 1965 and 1987 the cesarean section rate in the U.S. rose 455 percent, from 4.5 percent to 25 percent of births. While cesarean section was an appropriate and necessary procedure in a significant number of these births, the World Health Organization (WHO) has long estimated that the optimal cesarean section rate is between 5 and 10 percent of births and that a rate above 15 percent is apt to do more harm than good. Recent studies seem to corroborate WHO's assertion that the effects of a high cesarean section rate on a largely low-risk population are costly in both monetary and health terms. The proposed book will be the first in-depth social history of cesarean section in the 19th- and 20th- century U.S. and the first to examine the historical, cultural, and social issues, in addition to the medical factors, that have contributed to today's cesarean section rate of 32 percent. The book has four objectives: (1) To examine how the definition of “normal” labor and birth changed over the course of the nineteenth and twentieth centuries and to study the effect of that changing definition on lay and medical views of medical intervention during birth, particularly the performance of cesarean section. (2) To explore how standard obstetric treatment changed over this same period, particularly when medical personnel encountered a birth they deemed problematic. (3) To examine how the meaning of risk in relation to birth changed over time and to study how this change shaped medical and lay attitudes toward vaginal versus cesarean birth. (4) To study how historical, social, and cultural forces seemingly unrelated to health and medicine shape medical decisions and standard medical practices particularly in an arena such as birth, an event that represents so many societal hopes and concerns. In essence, this social history will examine the historical, social, cultural, and medical factors that shape standard obstetric practices, using cesarean section as a case study. As a historian of medicine, the P.I. will trace the social and cultural context of cesarean section over a roughly 200-year period from a time when the operation was among the most fatal of surgical procedures to the present day when the medical and lay communities view cesarean section as comparable and, at times, preferable to vaginal birth. Data for this book will be culled from oral history interviews with mothers and physicians and myriad archival and published sources including women's letters and diaries; physicians' personal papers; obstetric textbooks; articles in medical journals, newspapers, and magazines; doctors' casebooks; lying-in hospital casebooks; the papers of medical charities, home birthing services, lying-in hospitals, birth reform organizations, and medical and health insurance organizations; pregnancy and childbirth advice manuals; and physicians' and women's biographies and autobiographies.

Public Health Relevance Statement:

Project Narrative This social history of cesarean section in the United States over the last 200 years will examine the historical, cultural, social, and medical factors that have contributed to the current cesarean section rate of 32 percent. The World Health Organization (WHO) has long estimated that the optimal cesarean section rate is between 5 and 10 percent of births and that a rate above 15 percent is apt to do more harm than good and recent studies seem to corroborate WHO's assertion that the effects of a high cesarean section rate on a largely low-risk population are costly in both monetary and health terms. A thorough exploration of the historical emergence of cesarean section as a routine surgical intervention can help clarify the reasons for the lack of an evidence-based foundation for its frequency and, in doing so, aid in mitigating the current cesarean section rate and its negative effects on women's and children's health.

Project Start Date: 15-SEP-2011

Project End Date: 14-SEP-2014

Project Number: 1ZIAHD008794-05

NIDB Annual Report

Contact PI / Project Leader: SCHISTERMAN, ENRIQUE

Title: CONSORTIUM ON SAFE LABOR Awardee Organization: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT

Abstract Text: A consortium of 12 clincial institutions (19 hospitals) located in all nine districts of the American College of Obstetricians and Gynecologists in the U.S. provided electronic obstetric, labor and newborn data to create a perinatal database with more than 200,000 deliveries. Selected information were downloaded from the hospital databases and transferred in a de-identified format to the Data Coordinating Center for data auditing, cleaning, recoding and compilation. The de-identified database will be used for secondary data analyses to answer the following questions: What is the currect cesarean delivery practice in the U.S.? How can we reduce the cesarean delivery rate? What is the labor pattern in contemporary population? How to define normal and abnormal labor? When is the best time to perform a cesarean delivery in protracted labor? Answers to these questions may have important clinical implications.

CenterWatch: no relevant studies identified

Roche trials database: no relevant studies identified

Current Controlled Trials (international register): 2 relevant studies, both already published and indexed in PubMed (2005)

Foundation for the Advancement of Midwifery: no relevant studies identified

International Cesarean Awareness Network: no studies identified

American Association of Birth Centers: no studies identified

Hudson Valley Birth Network: no studies identified

Lamaze International: no studies identified

North American Registry of Midwives: no studies identified

American College of Nurse-Midwives: no studies identified