DystociaNCT02941393
Internal Versus External Tocodynamometry and Labor Outcome
A study testing Intrauterine pressure catheter and External tocodynamometry in people with Dystocia and Contractions, run by Tampere University Hospital at 2 sites in Finland.
Trial summary
In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dystocia, Contractions
- What is being tested?
- Intrauterine pressure catheter and External tocodynamometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesFinland
- Study dates
- Nov 2012to 31 Dec 2017
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- gestational age ≥ 37 weeks
- singleton pregnancy
- a fetus in cephalic position
- normal cardiotocograph in the time of randomization
- cervical ripening < 7 cm
- either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section
Who cannot join
- parturient with hepatitis or HIV or other significant viral infection
- Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
- Estimated fetal weight over 4,5 kg
- Suspected fetal abnormality
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Cetral Finland Central Hospital
Jyväskylä, Central Finland, 40640
Tampere University Hospital
Tampere, Pirkanmaa, 33520
About this study
Official title: Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn
In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn.
- Conditions
- Dystocia, Contractions
- Being tested
- Intrauterine pressure catheter, External tocodynamometry
- Keywords
- internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine pressure catheterDevice
Also called Internal tocodynamometry
External tocodynamometryDevice
| Study group | Role | What they receive |
|---|---|---|
| Intrauterine pressure catheter | Active comparator | Intrauterine pressure catheter is used during labor to follow up the contractions Receives: Device: Intrauterine pressure catheter |
| External tocodynamometry | Active comparator | External tocodynamometry is used during labor to follow up the contractions Receives: Device: External tocodynamometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cesarean sections
Measured: through study completion, an average of 6 years
Number of operative vaginal deliveries
Measured: through study completion, an average of 6 years
Secondary outcomes (5)
Duration of labor
Measured: From time of first regular contraction to birth
Newborn admission to the pediatric care unit
Measured: 3 days after birth
The use of Oxytocin during labor
Measured: From beginning of the use of oxytocin to the birth
Apgar scores
Measured: 10 min after birth
Ph of umbilical artery
Measured: immediately after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startNov 2012
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 DystociaStudies 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District
- Responsible party
- Principal investigator, Tuija Hautakangas, Tampere University Hospital
- Investigators
- Tuija Hautakangas, MD, Principal investigator, Central Finland Central Hospital, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941393
- Sponsor's protocol ID
- R12229
- Status last verified
- Mar 2018
- First submitted
- 7 Sep 2016
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Juhantalo M, Hautakangas T, Palomaki O, Uotila J. Uterine contractile activity thresholds associated with neonatal acidemia at term: A secondary analysis of a randomized controlled trial cohort. Int J Gynaecol Obstet. 2026 Jun 23. doi: 10.1002/ijgo.71151. Online ahead of print.
PubMed 42338233
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Measurement Method of Labor Contractions on Labor Outcome and Newborn
- ClinicalTrials.gov ID
- NCT02941393
- Acronym / sponsor ID
- R12229
- Conditions
- Dystocia, Contractions
- Keywords
- internal tocodynamometry, external tocodynamometry, cesarean section, labor, newborn, vacuum extraction, dystocia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District
- Study start
- Nov 2012
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 21 Oct 2016 (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.
In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrauterine pressure catheter | Active comparator | Device: Intrauterine pressure catheterIntrauterine pressure catheter is used during labor to follow up the contractions |
| External tocodynamometry | Active comparator | Device: External tocodynamometryExternal tocodynamometry is used during labor to follow up the contractions |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- gestational age ≥ 37 weeks
- singleton pregnancy
- a fetus in cephalic position
- normal cardiotocograph in the time of randomization
- cervical ripening < 7 cm
Key exclusion criteria (4 listed)
- parturient with hepatitis or HIV or other significant viral infection
- Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
- Estimated fetal weight over 4,5 kg
- Suspected fetal abnormality
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 |
|---|---|---|
| Intrauterine pressure catheterAlso: Internal tocodynamometry | Device | Intrauterine pressure catheter |
| External tocodynamometry | Device | External tocodynamometry |
Primary outcome
Number of cesarean sections
Time frame: through study completion, an average of 6 years
Number of operative vaginal deliveries
Time frame: through study completion, an average of 6 years
5 secondary outcomes
Duration of labor
Time frame: From time of first regular contraction to birth
Newborn admission to the pediatric care unit
Time frame: 3 days after birth
The use of Oxytocin during labor
Time frame: From beginning of the use of oxytocin to the birth
Apgar scores
Time frame: 10 min after birth
Ph of umbilical artery
Time frame: immediately after birth
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 Mar 2018.
- Derived from this study: PubMed 42338233Juhantalo M, Hautakangas T, Palomaki O, Uotila J. Uterine contractile activity thresholds associated with neonatal acidemia at term: A secondary analysis of a randomized controlled trial cohort. Int J Gynaecol Obstet. 2026 Jun 23. doi: 10.1002/ijgo.71151. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Dystocia
Active, not recruiting
Calcium Carbonate on Labor Induction
Pregnancy, Uterine Contraction
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
RecruitingPhase 4
Carbetocin Monotherapy Versus Carbetocin Plus Oxytocin Infusion in Elective Cesarean Delivery: A Non-Inferiority Trial
Postpartum Hemorrhage, Uterine Atony
Recruiting
Maternal Maneuvers During Prolonged Labor
Labor Stage, First, Prolonged Labor
Recruiting
Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy
Gynecological; Surgery (Previous), Causing Obstructed Labor
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.
Tuija Hautakangas, MD principal investigator
Central Finland Central Hospital, Tampere University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrauterine pressure catheter and External tocodynamometry in people with Dystocia and Contractions, run by Tampere University Hospital at 2 sites in Finland.
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 6 inclusion and 4 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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?
Number of cesarean sections (time frame: through study completion, an average of 6 years). The study lists 2 primary outcomes in all. 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 NCT02941393, 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 Mar 2018.