Perinatal MorbidityNCT00385229
Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
A study testing induction of labor in people with Perinatal Morbidity, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perinatal Morbidity
- What is being tested?
- induction of labor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2002to Jul 2004
- 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 Any age
- Women only
- Child, Adult, Older adult
Who may be able to join
- Routine ultrasound scan and delivery at St.Olav's Hospital
- Ability to speak Norwegian
- Singleton pregnancy
- Gestational age 289 +/- 2 days
- Cephalic presentation
Who cannot join
- prelabor rupture of membranes
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
Trondheim, 7006
About this study
Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences.
Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity.
Following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery
- Conditions
- Perinatal Morbidity
- Being tested
- induction of labor
- Keywords
- Asphyxia neonatorum, Birth Injury, Meconium Aspiration Syndrome
- Medical subject headings
- Asphyxia Neonatorum, Birth Injuries, Meconium Aspiration Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
induction of laborDrug
Misoprostol, Dinoprostone, amniotomy, Oxytocin
| Study group | Role | What they receive |
|---|---|---|
| Induction | Experimental | induction of labor at gestational age 289(41 weeks+2 days) Receives: Drug: induction of labor |
| expectant management | No intervention | expectant management at gestational age 289(41 weeks+2 days) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal morbidity
Measured: peri- en postnatal
Secondary outcomes (5)
Maternal complications
Measured: peri- and postnatal
Mode of delivery
Measured: at birth
women's view
Measured: postpartum
Women's experiences
Measured: perinatal
Hormone levels
Measured: perinatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startSep 2002
- Primary completionDec 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perinatal MorbidityStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Runa Heimstad, MD, Study director, Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385229
- Sponsor's protocol ID
- REK 106-01
- Status last verified
- Nov 2011
- First submitted
- 6 Oct 2006
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Heimstad R, Skogvoll E, Mattsson LA, Johansen OJ, Eik-Nes SH, Salvesen KA. Induction of labor or serial antenatal fetal monitoring in postterm pregnancy: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):609-17. doi: 10.1097/01.AOG.0000255665.77009.94.
PubMed 17329511Middleton P, Shepherd E, Morris J, Crowther CA, Gomersall JC. Induction of labour at or beyond 37 weeks' gestation. Cochrane Database Syst Rev. 2020 Jul 15;7(7):CD004945. doi: 10.1002/14651858.CD004945.pub5.
PubMed 32666584
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy
- ClinicalTrials.gov ID
- NCT00385229
- Acronym / sponsor ID
- REK 106-01
- Conditions
- Perinatal Morbidity
- Keywords
- Asphyxia neonatorum, Birth Injury, Meconium Aspiration Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Sep 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 9 Oct 2006 (estimated)
- 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.
Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences.
Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity.
Following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction | Experimental | Drug: induction of laborinduction of labor at gestational age 289(41 weeks+2 days) |
| expectant management | No intervention | –expectant management at gestational age 289(41 weeks+2 days) |
Who may qualify
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Routine ultrasound scan and delivery at St.Olav's Hospital
- Ability to speak Norwegian
- Singleton pregnancy
- Gestational age 289 +/- 2 days
- Cephalic presentation
Key exclusion criteria (1 listed)
- prelabor rupture of membranes
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 |
|---|---|---|
| induction of laborMisoprostol, Dinoprostone, amniotomy, Oxytocin | Drug | Induction |
Primary outcome
Neonatal morbidity
Time frame: peri- en postnatal
5 secondary outcomes
Maternal complications
Time frame: peri- and postnatal
Mode of delivery
Time frame: at birth
women's view
Time frame: postpartum
Women's experiences
Time frame: perinatal
Hormone levels
Time frame: perinatal
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 4 Nov 2011.
- Results publication: PubMed 17329511Heimstad R, Skogvoll E, Mattsson LA, Johansen OJ, Eik-Nes SH, Salvesen KA. Induction of labor or serial antenatal fetal monitoring in postterm pregnancy: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):609-17. doi: 10.1097/01.AOG.0000255665.77009.94.
- Derived from this study: PubMed 32666584Middleton P, Shepherd E, Morris J, Crowther CA, Gomersall JC. Induction of labour at or beyond 37 weeks' gestation. Cochrane Database Syst Rev. 2020 Jul 15;7(7):CD004945. doi: 10.1002/14651858.CD004945.pub5.
Related trials for Perinatal Morbidity
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
Recruiting
Improving Safety, Patient Experience and Equity Through Shared Decision-making Huddles in Labor
Perinatal Decision Making
Active, not recruiting
Doula Model of Care
Perinatal, Morbidity
Recruiting
Enriched Holistic Care to Eradicate Disparities in Maternal Morbidity
Morbidity;Perinatal
Recruiting
Impact of First-trimester Preeclampsia Screening on Perinatal and Maternal Morbidity (RANSPRE)
Preeclampsia (PE)
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.
Runa Heimstad, MD study director
Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing induction of labor in people with Perinatal Morbidity, run by St. Olavs Hospital at 1 site in Norway.
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 5 inclusion and 1 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 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Neonatal morbidity (time frame: peri- en postnatal). 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 NCT00385229, which also lists 2 linked publications.
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 4 Nov 2011.