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When to INDuce for OverWeight? (WINDOW) (WINDOW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04603859
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : May 2, 2022
Sponsor:
Collaborators:
Aarhus University Hospital
Randers Regional Hospital
Herning Hospital
Central Jutland Regional Hospital
Nykøbing Falster Sygehus
Odense University Hospital
Rigshospitalet Juliane Marie Centret
Kolding Sygehus
Herlev Hospital
Hvidovre University Hospital
North Zealand's Hospital
Information provided by (Responsible Party):
Lise Krogh, University of Aarhus

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Obesity Parturition Procedure: Elective induction of labor at 39 gestational weeks and 0 to 3 days Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Elective induction of labour
Elective induction of labour at 39 gestational weeks and 0 to 3 days.
Procedure: Elective induction of labor at 39 gestational weeks and 0 to 3 days
Elective induction of labor (eIOL) according to local policies
Other Name: eIOL

No Intervention: Expectant management
Awaiting spontaneous labor.



Primary Outcome Measures :
  1. Caesarean section [ Time Frame: At delivery ]
    number (no.)


Secondary Outcome Measures :
  1. Mode of delivery if not by caesarean [ Time Frame: At delivery ]
    • Vaginal delivery - no.
    • Vaginal assisted delivery - no.

  2. Mode of delivery [ Time Frame: At delivery ]
    • Caesarean section - percent
    • Vaginal delivery - percent
    • Vaginal assisted delivery - percent

  3. Vaginal assisted delivery [ Time Frame: At delivery ]
    • Forceps - no.
    • Ventouse - no.

  4. Indication for caesarean section (more than one indication is possible) [ Time Frame: At delivery ]
    • 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.

  5. Indication for vaginal assisted delivery (more than one is possible) [ Time Frame: At delivery ]
    • Labour dystocia - no.
    • Fetal distress - no.
    • Maternal request - no.
    • Other indication for assisted vaginal delivery (free text) - no.

  6. Use of epidural [ Time Frame: At delivery ]
    no.

  7. Damage to internal organs (bladder, bowel or ureters) [ Time Frame: At delivery to 30 days postpartum ]
    no.

  8. Uterine scar dehiscense or rupture [ Time Frame: At delivery ]
    no.

  9. Complications [ Time Frame: At delivery ]
    • 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.

  10. Postpartum haemorrhage [ Time Frame: 0-2 hours postpartum ]
    • Blood loss >500ml - no.
    • Blood loss >1000ml - no.
    • Blood transfusion - no. Time Frame [0-2 days postpartum]

  11. Hysterectomy [ Time Frame: At delivery to 30 days postpartum ]
    no.

  12. Postpartum morbidity [ Time Frame: 0-30 days postpartum ]
    • Puerperal infection treated in hospital - no.
    • Other severe postpartum conditions treated in hospital (free text) - no.

  13. Maternal admission to Intensive Care Unit [ Time Frame: Enrollment to 30 days postpartum ]
    no.

  14. Maternal cardiopulmonary arrest [ Time Frame: Enrollment to 30 days postpartum ]
    no.

  15. Maternal death [ Time Frame: Enrollment to 30 days postpartum ]
    no.

  16. Primary neonatal composite including any of the following; [ Time Frame: Enrollment to 28 days of life ]
    • 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

  17. Components of the primary neonatal composite will additionally be reported separately [ Time Frame: Enrollment to 28 days of life ]
    • 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.

  18. Neonatal trauma composite including any of the following; [ Time Frame: At delivery to 28 days of life ]
    • Birth trauma (bone fracture, Duchenne-Erbs palsy, or retinal hemorrhage)
    • Intracranial or subgaleal hemorrhage

  19. Neonatal asphyxia composite including any of the following; [ Time Frame: At delivery to 28 days of life ]
    • 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)

  20. Apgar score at 5 minutes [ Time Frame: 5 minutes of life ]
    • Apgar score <4 - no.
    • Apgar score of 4-7 - no.

  21. Umbilical cord arterial and venous blood sample (allow missing data) [ Time Frame: 0-30 minutes of life ]
    • pH-value < 7.0 - no.
    • sBE < -15.0 mmol/l - no.

  22. Neonatal admission [ Time Frame: 0-72 hours of life ]
    no.

  23. Respiratory support during neonatal admission [ Time Frame: 0-28 days of life ]
    • CPAP (y/n) - no.
    • HNFC (y/n) - no.
    • Oxygen supplement treatment (y/n) - no.
    • Ventilator treatment (y/n) - no.

  24. Other treatment during neonatal admission [ Time Frame: 0-28 days of life ]
    • Therapeutic hypothermia (y/n) - no.
    • Vasopressor support (y/n) - no.
    • Antibiotic treatment continuously for 7 days minimum (y/n) - no.


Other Outcome Measures:
  1. Neonatal characteristics 1 [ Time Frame: At delivery ]
    • Female sex - no.
    • Birth weight > 4500 grams (y/n) - no.

  2. Neonatal characteristics 2 [ Time Frame: At delivery ]
    - Mean birth weight - grams

  3. Maternal experience on birth [ Time Frame: 4-6 weeks postpartum ]
    Childbirth Experience Questionnaire Scoring range is 1 to 4 where higher ratings reflect more positive experiences

  4. Maternal postnatal depression [ Time Frame: 4-6 weeks postpartum ]
    • Major Depression Inventory (MDI)
    • Edinburgh Postnatal Depression Score Scoring range is 1 to 4 where higher ratings reflect more positive experiences



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603859


Contacts
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Contact: Lise Q Krogh, MD 0045 51242102 lise.qvirin.krogh@clin.au.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Lise Q Krogh, MD         
Herlev Hospital Recruiting
Herlev, Denmark
Contact: Lene Huusom, MD, PhD         
Gødstrup Regional Hospital Recruiting
Herning, Denmark
Contact: Rubab Krogh, MD         
North Zealand's Hospital Not yet recruiting
Hillerød, Denmark
Contact: Hanne B Westergaard, MD, PhD         
Hvidovre Hospital Recruiting
Hvidovre, Denmark
Contact: Lone Krebs, MD, PhD         
Kolding Hospital Recruiting
Kolding, Denmark
Contact: Annemette W Lykkebo, MD         
Rigshospitalet Juliane Marie Centre Recruiting
København, Denmark
Contact: Kristina Renault, MD, DMSc         
Nykøbing Falster Hospital Recruiting
Nykøbing Falster, Denmark
Contact: Jeannet Lauenborg, MD, PhD         
Odense University Hospital Recruiting
Odense, Denmark
Contact: Christina Vinter, MD, PhD         
Randers Regional Hospital Recruiting
Randers, Denmark
Contact: Pinar Bor, MD, PhD         
Viborg Hospital Recruiting
Viborg, Denmark
Contact: Lise Clausen, MD         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Randers Regional Hospital
Herning Hospital
Central Jutland Regional Hospital
Nykøbing Falster Sygehus
Odense University Hospital
Rigshospitalet Juliane Marie Centret
Kolding Sygehus
Herlev Hospital
Hvidovre University Hospital
North Zealand's Hospital
Investigators
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Principal Investigator: Lise Q Krogh, MD Aarhus University Hospital
Study Chair: Julie Glavind, MD, PhD Aarhus University Hospital
Study Chair: Sidsel Boie, MD, PhD Randers Regional Hospital
Study Chair: Jens Fuglsang, MD, PhD Aarhus University Hospital
Study Chair: Tine B Henriksen, MD, PhD Aarhus University Hospital
Study Chair: Jim Thornton, MD, PhD Nottingham University
Study Chair: Katja A Taastrøm, Midwife, MSc Aarhus University Hospital
Study Chair: Anne Cathrine M Kjeldsen, Midwife, MSc Aarhus University Hospital
  Study Documents (Full-Text)

Documents provided by Lise Krogh, University of Aarhus:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lise Krogh, Principal Investigator, University of Aarhus
ClinicalTrials.gov Identifier: NCT04603859    
Other Study ID Numbers: WINDOW
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The final dataset will be publicly available in an anonymised form using an open data repository (i.e. CERN) or another equivalent database.

All relevant trial-related documents will be shared along with the data.

Time Frame: Beginning three months and ending three years after the publication of the last trial results.
Access Criteria: Data will be available for any research purpose to all interested parties who have approval from an independent review committee. Interested parties will be able to request the data by contacting the trial sponsor. Authorship of publications emerging from the shared data will follow standard authorship guidelines and will include authors from the WINDOW study group depending on the nature of their involvement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lise Krogh, University of Aarhus:
Induction of labor
Expectant management
Cesarean section
Additional relevant MeSH terms:
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Overweight
Body Weight