PregnancyWINDOWNCT04603859
When to INDuce for OverWeight? (WINDOW)
A study testing Elective induction of labor at 39 gestational weeks and 0 to 3 days in people with Pregnancy and Obesity, run by University of Aarhus at 12 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Obesity, Parturition
- What is being tested?
- Elective induction of labor at 39 gestational weeks and 0 to 3 days
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,901 participants
- Where
- 12 sitesDenmark
- Study dates
- 19 Oct 2020to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women with pre- or early pregnancy BMI ≥ 30 kg/m2
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Denmark12 sites
Aarhus University Hospital
Aarhus
Rigshospitalet Juliane Marie Centre
Copenhagen
Herlev Hospital
Herlev
Gødstrup Regional Hospital
Herning
North Zealand's Hospital
Hillerød
Hvidovre Hospital
Hvidovre
Kolding Hospital
Kolding
Nykøbing Falster Hospital
Nykøbing Falster
Odense University Hospital
Odense
Randers Regional Hospital
Randers
Zealand University Hospital
Roskilde
Viborg Hospital
Viborg
About this study
Official title: When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)
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.
Read the detailed description
Background The World Health Organization (WHO) defines overweight as a body mass index (BMI) of ≥25 kg/m2 and obesity as a BMI of ≥30 kg/m2. Overweight and obesity are rising dramatically worldwide. In fertile women, the prevalence of obesity is one third in the United States, 20% in the United Kingdom, and 12-13% in Denmark. The association between obesity in pregnancy and the risk of gestational complications increases with increasing BMI. Among other complications, obesity in pregnancy is associated with increased risk of caesarean delivery. Delivery by caesarean section further adds significant risks of wound infection or other infectious morbidity in obese women as compared to normal weight women. The longer the woman is pregnant, the longer the risk of pregnancy complications remains. In an otherwise low-risk pregnant woman at term, it is an on-going clinical dilemma, whether the benefits of elective induction of labor (eIOL) and termination of the pregnancy will outweigh the potential harms from the concomitant induction and delivery process. Regarding delivery complications, based on data from historical cohorts, eIOL has traditionally been associated with an increased risk of caesarean section and instrumental delivery. Therefore, expectant management has been the preferred clinical option. This interpretation has now been challenged by a randomized trial (ARRIVE) with >6000 low-risk pregnant women where eIOL at 39 weeks of gestation was associated with lower caesarean delivery rates. There are no randomized studies in obese women, but two larger observational studies did find lower odds of caesarean delivery in obese women with eIOL as compared to awaiting labor onset. Hence, a randomized trial that would compare caesarean delivery among obese women whose labor is induced with those expectantly managed is warranted. The proposed study will provide new and important knowledge into the area of induction of labor among overweight and obese women with potential great international impact for the future raising number of pregnant women in this subgroup.
With this trial, the investigators aim to compare the risk of caesarean section in obese (BMI ≥ 30 kg/m2), but otherwise low-risk women with eIOL as compared to expectant management.
Materials and methods
The study is a multicenter randomized controlled trial with an allocation ratio of 1:1 in the two following arms:
- Intervention arm/elective induction of labor in pregnancy at 39 gestational week and 0 to 3 days: Induction is performed according to local policy for induction of labor.
- Comparison arm/expectant management: Waiting for spontaneous onset of labor unless a situation develops necessitating either induction of labor or caesarean section. 1900 low-risk pregnant women with a pre- or early pregnancy BMI ≥ 30 carrying a singleton pregnancy will be recruited from the Danish delivery wards. In each trial site, a physician investigator will be responsible for the enrolment, the electronically randomization, and data collection.
The primary endpoint is the caesarean section rate. Among others there will be secondary endpoints on instrumental delivery, onset of labor, methods of induction, perinatal and postpartum complications both maternal and neonatal along with data on women's experience on birth measured by a questionnaire survey four to six weeks post-partum.
Ethics The study will be conducted in accordance with the ethical principles outlined in the latest version of the 'Declaration of Helsinki' and the 'Guideline for Good Clinical Practice' related to experiments on humans. The Central Denmark Region Committee on Biomedical Research Ethics, and The Danish Health Authorities have approved the study.
Perspectives In perspective, more than 39% of the world's population is overweight and 13% are obese by the WHO classification. Pregnant overweight women are at increased risk of pregnancy and delivery complications, and there is a need to improve maternity care for this subgroup of women. The results of this trial have the potential to generate important knowledge for the improvement of delivery in obese women and they will add key information to an on-going discussion of the effects of labor induction before term. Any possible harm or disadvantage to the individual study participant is outweighed by the possible benefit to the increasing number of obese women who will be pregnant in the future.
- Conditions
- Pregnancy, Obesity, Parturition
- Being tested
- Elective induction of labor at 39 gestational weeks and 0 to 3 days
- Keywords
- Induction of labor, Expectant management, Cesarean section
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective induction of labor at 39 gestational weeks and 0 to 3 daysProcedure or surgery
Also called eIOL
Elective induction of labor (eIOL) according to local policies
| Study group | Role | What they receive |
|---|---|---|
| Elective induction of labour | Experimental | Elective induction of labour at 39 gestational weeks and 0 to 3 days. Receives: Procedure: Elective induction of labor at 39 gestational weeks and 0 to 3 days |
| Expectant management | No intervention | Awaiting spontaneous labor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caesarean section
number (no.)
Measured: At delivery
Secondary outcomes (24)
Mode of delivery if not by caesarean
- Vaginal delivery - no.
- Vaginal assisted delivery - no.
Measured: At delivery
Mode of delivery
- Caesarean section - percent
- Vaginal delivery - percent
- Vaginal assisted delivery - percent
Measured: At delivery
Vaginal assisted delivery
- Forceps - no.
- Ventouse - no.
Measured: At delivery
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.
Measured: At delivery
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.
Measured: At delivery
Use of epidural
no.
Measured: At delivery
Damage to internal organs (bladder, bowel or ureters)
no.
Measured: At delivery to 30 days postpartum
Uterine scar dehiscense or rupture
no.
Measured: At delivery
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.
Measured: At delivery
Postpartum haemorrhage
- Blood loss >500ml - no.
- Blood loss >1000ml - no.
- Blood transfusion - no. Time Frame [0-2 days postpartum]
Measured: 0-2 hours postpartum
Hysterectomy
no.
Measured: At delivery to 30 days postpartum
Postpartum morbidity
- Puerperal infection treated in hospital - no.
- Other severe postpartum conditions treated in hospital (free text) - no.
Measured: 0-30 days postpartum
Maternal admission to Intensive Care Unit
no.
Measured: Enrollment to 30 days postpartum
Maternal cardiopulmonary arrest
no.
Measured: Enrollment to 30 days postpartum
Maternal death
no.
Measured: Enrollment to 30 days postpartum
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
Measured: Enrollment to 28 days of life
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.
Measured: Enrollment to 28 days of life
Neonatal trauma composite including any of the following;
- Birth trauma (bone fracture, Duchenne-Erbs palsy, or retinal hemorrhage)
- Intracranial or subgaleal hemorrhage
Measured: At delivery to 28 days of life
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)
Measured: At delivery to 28 days of life
Apgar score at 5 minutes
- Apgar score <4 - no.
- Apgar score of 4-7 - no.
Measured: 5 minutes of life
Umbilical cord arterial and venous blood sample (allow missing data)
- pH-value < 7.0 - no.
- sBE < -15.0 mmol/l - no.
Measured: 0-30 minutes of life
Neonatal admission
no.
Measured: 0-72 hours of life
Respiratory support during neonatal admission
- CPAP (y/n) - no.
- HNFC (y/n) - no.
- Oxygen supplement treatment (y/n) - no.
- Ventilator treatment (y/n) - no.
Measured: 0-28 days of life
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.
Measured: 0-28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start19 Oct 2020
- Primary completion10 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,901 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Randers Regional Hospital, Herning Hospital, Central Jutland Regional Hospital, Nykøbing Falster County Hospital, Odense University Hospital, Rigshospitalet Juliane Marie Centret, Kolding Sygehus, Herlev Hospital, Hvidovre University Hospital, North Zealand's Hospital, Zealand University Hospital - Roskilde
- Responsible party
- Principal investigator, Lise Krogh, University of Aarhus
- Investigators
- Lise Q Krogh, MD, Principal investigator, Aarhus University HospitalJulie Glavind, MD, PhD, Study chair, Aarhus University HospitalSidsel Boie, MD, PhD, Study chair, Randers Regional HospitalJens Fuglsang, MD, PhD, Study chair, Aarhus University HospitalTine B Henriksen, MD, PhD, Study chair, Aarhus University HospitalJim Thornton, MD, PhD, Study chair, Nottingham UniversityKatja A Taastrøm, Midwife, MSc, Study chair, Aarhus University HospitalAnne Cathrine M Kjeldsen, Midwife, MSc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603859
- Sponsor's protocol ID
- WINDOW
- Acronym
- WINDOW
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2020
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Krogh LQ, Boie S, Henriksen TB, Thornton J, Fuglsang J, Glavind J. Induction of labour at 39 weeks versus expectant management in low-risk obese women: study protocol for a randomised controlled study. BMJ Open. 2022 Apr 25;12(4):e057688. doi: 10.1136/bmjopen-2021-057688.
PubMed 35470194
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- When to INDuce for OverWeight? - a Randomised Controlled Trial (WINDOW)
- ClinicalTrials.gov ID
- NCT04603859
- Acronym / sponsor ID
- WINDOW / WINDOW
- Conditions
- Pregnancy, Obesity, Parturition
- Keywords
- Induction of labor, Expectant management, Cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,901 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Randers Regional Hospital, Herning Hospital, Central Jutland Regional Hospital, Nykøbing Falster County Hospital, Odense University Hospital, Rigshospitalet Juliane Marie Centret, Kolding Sygehus, Herlev Hospital, Hvidovre University Hospital, North Zealand's Hospital, Zealand University Hospital - Roskilde
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 10 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background The World Health Organization (WHO) defines overweight as a body mass index (BMI) of ≥25 kg/m2 and obesity as a BMI of ≥30 kg/m2. Overweight and obesity are rising dramatically worldwide. In fertile women, the prevalence of obesity is one third in the United States, 20% in the United Kingdom, and 12-13% in Denmark. The association between obesity in pregnancy and the risk of gestational complications increases with increasing BMI. Among other complications, obesity in pregnancy is associated with increased risk of caesarean delivery. Delivery by caesarean section further adds significant risks of wound infection or other infectious morbidity in obese women as compared to normal weight women. The longer the woman is pregnant, the longer the risk of pregnancy complications remains. In an otherwise low-risk pregnant woman at term, it is an on-going clinical dilemma, whether the benefits of elective induction of labor (eIOL) and termination of the pregnancy will outweigh the potential harms from the concomitant induction and delivery process. Regarding delivery complications, based on data from historical cohorts, eIOL has traditionally been associated with an increased risk of caesarean section and instrumental delivery. Therefore, expectant management has been the preferred clinical option. This interpretation has now been challenged by a randomized trial (ARRIVE) with >6000 low-risk pregnant women where eIOL at 39 weeks of gestation was associated with lower caesarean delivery rates. There are no randomized studies in obese women, but two larger observational studies did find lower odds of caesarean delivery in obese women with eIOL as compared to awaiting labor onset. Hence, a randomized trial that would compare caesarean delivery among obese women whose labor is induced with those expectantly managed is warranted. The proposed study will provide new and important knowledge into the area of induction of labor among overweight and obese women with potential great international impact for the future raising number of pregnant women in this subgroup.
With this trial, the investigators aim to compare the risk of caesarean section in obese (BMI ≥ 30 kg/m2), but otherwise low-risk women with eIOL as compared to expectant management.
Materials and methods
The study is a multicenter randomized controlled trial with an allocation ratio of 1:1 in the two following arms:
- Intervention arm/elective induction of labor in pregnancy at 39 gestational week and 0 to 3 days: Induction is performed according to local policy for induction of labor.
- Comparison arm/expectant management: Waiting for spontaneous onset of labor unless a situation develops necessitating either induction of labor or caesarean section. 1900 low-risk pregnant women with a pre- or early pregnancy BMI ≥ 30 carrying a singleton pregnancy will be recruited from the Danish delivery wards. In each trial site, a physician investigator will be responsible for the enrolment, the electronically randomization, and data collection.
The primary endpoint is the caesarean section rate. Among others there will be secondary endpoints on instrumental delivery, onset of labor, methods of induction, perinatal and postpartum complications both maternal and neonatal along with data on women's experience on birth measured by a questionnaire survey four to six weeks post-partum.
Ethics The study will be conducted in accordance with the ethical principles outlined in the latest version of the 'Declaration of Helsinki' and the 'Guideline for Good Clinical Practice' related to experiments on humans. The Central Denmark Region Committee on Biomedical Research Ethics, and The Danish Health Authorities have approved the study.
Perspectives In perspective, more than 39% of the world's population is overweight and 13% are obese by the WHO classification. Pregnant overweight women are at increased risk of pregnancy and delivery complications, and there is a need to improve maternity care for this subgroup of women. The results of this trial have the potential to generate important knowledge for the improvement of delivery in obese women and they will add key information to an on-going discussion of the effects of labor induction before term. Any possible harm or disadvantage to the individual study participant is outweighed by the possible benefit to the increasing number of obese women who will be pregnant in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective induction of labour | Experimental | Procedure: Elective induction of labor at 39 gestational weeks and 0 to 3 daysElective induction of labour at 39 gestational weeks and 0 to 3 days. |
| Expectant management | No intervention | –Awaiting spontaneous labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women with pre- or early pregnancy BMI ≥ 30 kg/m2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective induction of labor at 39 gestational weeks and 0 to 3 daysAlso: eIOLElective induction of labor (eIOL) according to local policies | Procedure or surgery | Elective induction of labour |
Primary outcome
Caesarean section
Time frame: At delivery
number (no.)
24 secondary outcomes
Mode of delivery if not by caesarean
Time frame: At delivery
Mode of delivery
Time frame: At delivery
Vaginal assisted delivery
Time frame: At delivery
Indication for caesarean section (more than one indication is possible)
Time frame: At delivery
Indication for vaginal assisted delivery (more than one is possible)
Time frame: At delivery
Use of epidural
Time frame: At delivery
Damage to internal organs (bladder, bowel or ureters)
Time frame: At delivery to 30 days postpartum
Uterine scar dehiscense or rupture
Time frame: At delivery
Complications
Time frame: At delivery
Postpartum haemorrhage
Time frame: 0-2 hours postpartum
Hysterectomy
Time frame: At delivery to 30 days postpartum
Postpartum morbidity
Time frame: 0-30 days postpartum
Maternal admission to Intensive Care Unit
Time frame: Enrollment to 30 days postpartum
Maternal cardiopulmonary arrest
Time frame: Enrollment to 30 days postpartum
Maternal death
Time frame: Enrollment to 30 days postpartum
Primary neonatal composite including any of the following;
Time frame: Enrollment to 28 days of life
Components of the primary neonatal composite will additionally be reported separately
Time frame: Enrollment to 28 days of life
Neonatal trauma composite including any of the following;
Time frame: At delivery to 28 days of life
Neonatal asphyxia composite including any of the following;
Time frame: At delivery to 28 days of life
Apgar score at 5 minutes
Time frame: 5 minutes of life
Umbilical cord arterial and venous blood sample (allow missing data)
Time frame: 0-30 minutes of life
Neonatal admission
Time frame: 0-72 hours of life
Respiratory support during neonatal admission
Time frame: 0-28 days of life
Other treatment during neonatal admission
Time frame: 0-28 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 35470194Krogh LQ, Boie S, Henriksen TB, Thornton J, Fuglsang J, Glavind J. Induction of labour at 39 weeks versus expectant management in low-risk obese women: study protocol for a randomised controlled study. BMJ Open. 2022 Apr 25;12(4):e057688. doi: 10.1136/bmjopen-2021-057688.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Q Krogh, MD principal investigator
Aarhus University Hospital
Julie Glavind, MD, PhD study chair
Aarhus University Hospital
Sidsel Boie, MD, PhD study chair
Randers Regional Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective induction of labor at 39 gestational weeks and 0 to 3 days in people with Pregnancy and Obesity, run by University of Aarhus at 12 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caesarean section (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.