Obesity Clinical Trial
— WINDOWOfficial title:
When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)
NCT number | NCT04603859 |
Other study ID # | WINDOW |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 19, 2020 |
Est. completion date | June 2026 |
The rate of overweight and obese women becoming pregnant is increasing. Obesity in pregnancy along with delivery by cesarean section in obese women is associated with several complications as compared to normal weight women. The longer the woman is pregnant, the longer she is at risk. In an otherwise low-risk pregnant woman at term, it is an ongoing clinical dilemma, whether the benefits of elective induction of labor and termination of the pregnancy will outweigh the potential harms from concomitant induction and delivery process. The proposed study is a randomized controlled study of elective induction versus expectant management in obese women. The study will be carried out as a national multicenter study with inclusion of 1900 participants from Danish delivery wards. The null hypothesis is that the caesarean section rate is similar with elective induction of labor at 39 weeks of gestation, compared with expectant management among pregnant women with pre- or early pregnancy BMI≥30.
Status | Recruiting |
Enrollment | 1900 |
Est. completion date | June 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: • Pregnant women with pre- or early pregnancy BMI = 30 kg/m2 Exclusion Criteria: - Legal or ethical considerations: maternal age <18 years, language difficulties requiring an interpreter or translator - Multiple pregnancy - Previous caesarean section - Uncertain gestational age, defined as gestational age determined by other measurements than the Crown-Rump length (CRL) Measurement - Planned elective caesarean section at time of randomisation - Fetal contraindications to IOL at time of randomisation: e.g. non-cephalic presentation, or other fetal conditions contraindicating vaginal delivery - Fetal contraindications to expectant management at time of randomisation - Maternal contraindications to IOL at time of randomisation: e.g. placenta previa/accreta, vasa previa - Maternal contraindications to expectant management at time of randomisation: e.g. maternal medical conditions, ultrasonically diagnosed oligohydramnios (DVP< 2 cm), signs of labour including pre-labour rupture of membranes (PROM) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital | Aarhus | |
Denmark | Herlev Hospital | Herlev | |
Denmark | Gødstrup Regional Hospital | Herning | |
Denmark | North Zealand's Hospital | Hillerød | |
Denmark | Hvidovre Hospital | Hvidovre | |
Denmark | Rigshospitalet Juliane Marie Centre | København | |
Denmark | Kolding Hospital | Kolding | |
Denmark | Nykøbing Falster Hospital | Nykøbing Falster | |
Denmark | Odense University Hospital | Odense | |
Denmark | Randers Regional Hospital | Randers | |
Denmark | Zealand University Hospital | Roskilde | |
Denmark | Viborg Hospital | Viborg |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus | Aarhus University Hospital, Central Jutland Regional Hospital, Herlev Hospital, Herning Hospital, Hvidovre University Hospital, Kolding Sygehus, North Zealand's Hospital, Nykøbing Falster County Hospital, Odense University Hospital, Randers Regional Hospital, Rigshospitalet Juliane Marie Centret, Zealand University Hospital - Roskilde |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Neonatal characteristics 1 | Female sex - no.
Birth weight > 4500 grams (y/n) - no. |
At delivery | |
Other | Neonatal characteristics 2 | - Mean birth weight - grams | At delivery | |
Other | Maternal experience on birth | Childbirth Experience Questionnaire Scoring range is 1 to 4 where higher ratings reflect more positive experiences | 4-6 weeks postpartum | |
Other | Maternal postnatal depression | Major Depression Inventory (MDI)
Edinburgh Postnatal Depression Score Scoring range is 1 to 4 where higher ratings reflect more positive experiences |
4-6 weeks postpartum | |
Primary | Caesarean section | number (no.) | At delivery | |
Secondary | Mode of delivery if not by caesarean | Vaginal delivery - no.
Vaginal assisted delivery - no. |
At delivery | |
Secondary | Mode of delivery | Caesarean section - percent
Vaginal delivery - percent Vaginal assisted delivery - percent |
At delivery | |
Secondary | Vaginal assisted delivery | Forceps - no.
Ventouse - no. |
At delivery | |
Secondary | Indication for caesarean section (more than one indication is possible) | Labour dystocia - no.
Fetal distress - no. Maternal request - no. Suspected macrosomia - no. Non-cephalic presentation - no. Extensive vaginal bleeding - no. Suspected uterine rupture - no. Maternal or fetal complication/condition (free text) - no. Other indication for caesarean section (free text) - no. |
At delivery | |
Secondary | Indication for vaginal assisted delivery (more than one is possible) | Labour dystocia - no.
Fetal distress - no. Maternal request - no. Other indication for assisted vaginal delivery (free text) - no. |
At delivery | |
Secondary | Use of epidural | no. | At delivery | |
Secondary | Damage to internal organs (bladder, bowel or ureters) | no. | At delivery to 30 days postpartum | |
Secondary | Uterine scar dehiscense or rupture | no. | At delivery | |
Secondary | Complications | Minor shoulder dystocia defined as the need for McRobert's maneuver - no.
Major shoulder dystocia defined as the need for procedures other than McRobert's maneuver - no. Clinical suspicion of abruption of the placenta leading to an intervention in labour - no. Cord prolapse - no. Maternal fever defined as temperature >38,2 / >38,0 degrees celsius with / without epidural - no. Perineal 3rd degree laceration - no. Perineal 4th degree laceration - no. Episiotomy - no. |
At delivery | |
Secondary | Postpartum haemorrhage | Blood loss >500ml - no.
Blood loss >1000ml - no. Blood transfusion - no. Time Frame [0-2 days postpartum] |
0-2 hours postpartum | |
Secondary | Hysterectomy | no. | At delivery to 30 days postpartum | |
Secondary | Postpartum morbidity | Puerperal infection treated in hospital - no.
Other severe postpartum conditions treated in hospital (free text) - no. |
0-30 days postpartum | |
Secondary | Maternal admission to Intensive Care Unit | no. | Enrollment to 30 days postpartum | |
Secondary | Maternal cardiopulmonary arrest | no. | Enrollment to 30 days postpartum | |
Secondary | Maternal death | no. | Enrollment to 30 days postpartum | |
Secondary | Primary neonatal composite including any of the following; | Perinatal death (stillbirth and neonatal)
The need for respiratory support if admitted to a neonatal department (intubation and mechanical ventilation, oxygen, continuous positive airway pressure (CPAP), or high-flow nasal cannula (HNFC)). Time Frame [within 72 hours after birth] Apgar score < 4 at 5 minutes Hypoxic-ischemic encephalopathy (defined as the need for therapeutic hypothermia) Seizures Infection (defined as antibiotic treatment continuously for 7 days minimum) Meconium aspiration syndrome Birth trauma (bone fracture, Duchenne-Erbs palsy, or retinal hemorrhage) Intracranial or subgaleal hemorrhage Hypotension requiring vasopressor support |
Enrollment to 28 days of life | |
Secondary | Components of the primary neonatal composite will additionally be reported separately | Perinatal death (stillbirth and neonatal) - no.
The need for respiratory support if admitted to a neonatal department (intubation and mechanical ventilation, oxygen, continuous positive airway pressure (CPAP), or high-flow nasal cannula (HNFC)). Time Frame [within 72 hours after birth] - no. Apgar score < 4 at 5 minutes - no. Hypoxic-ischemic encephalopathy (defined as the need for therapeutic hypothermia) - no. Seizures - no. Infection (defined as antibiotic treatment continuously for 7 days minimum) - no. Meconium aspiration syndrome - no. Birth trauma (bone fracture, Duchenne-Erbs palsy, or retinal hemorrhage) - no. Intracranial or subgaleal hemorrhage - no. Hypotension requiring vasopressor support - no. |
Enrollment to 28 days of life | |
Secondary | Neonatal trauma composite including any of the following; | Birth trauma (bone fracture, Duchenne-Erbs palsy, or retinal hemorrhage)
Intracranial or subgaleal hemorrhage |
At delivery to 28 days of life | |
Secondary | Neonatal asphyxia composite including any of the following; | Apgar score < 4 at 5 minutes
Umbilical cord pH-value < 7.0 (allow missing data) Umbilical cord standard base excess (sBE) < -15.0 mmol/l (allow missing data) Seizures Hypoxic-ischemic encephalopathy (defined as the need for therapeutic hypothermia) |
At delivery to 28 days of life | |
Secondary | Apgar score at 5 minutes | Apgar score <4 - no.
Apgar score of 4-7 - no. |
5 minutes of life | |
Secondary | Umbilical cord arterial and venous blood sample (allow missing data) | pH-value < 7.0 - no.
sBE < -15.0 mmol/l - no. |
0-30 minutes of life | |
Secondary | Neonatal admission | no. | 0-72 hours of life | |
Secondary | Respiratory support during neonatal admission | CPAP (y/n) - no.
HNFC (y/n) - no. Oxygen supplement treatment (y/n) - no. Ventilator treatment (y/n) - no. |
0-28 days of life | |
Secondary | Other treatment during neonatal admission | Therapeutic hypothermia (y/n) - no.
Vasopressor support (y/n) - no. Antibiotic treatment continuously for 7 days minimum (y/n) - no. |
0-28 days of life |
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