Prolonged LaborNCT00915148
Ultrasound Prediction of Prolonged Labour
An observational study of Prolonged Labor, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Prolonged Labor
- What is being tested?
- Ultrasound examination
- How many people
- 110 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2008to Aug 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primi gravidae, with one fetus, after the 37th week. Cephalic presentation. Prolonged first stage according to WHO definitions.
Who may be able to join
- Primi gravidae
- >37th week
- Cephalic presentation
- Prolonged first stage according to WHO definitions.
Who cannot join
- Multiple pregnancies
- Intrauterine fetal death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First Stage 3D-ultrasound During Prolonged Labour.
This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.
Read the detailed description
AIM:
To correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.
Objective:
Labours have traditionally been evaluated by manuals methods of the "delivery helper" - midwives or doctor. There are many factors that will prolong labour such as malcontractions, disproportion of the birth canal and malpresentation/position. In about 20% of primigravidae, the first stage will last longer than 10 hours.
In this study we want to evaluate different ultrasounds measurements to see if ultrasound can be used to predict the outcome of labour.
Methods:
A descriptive observational study, with one ultrasound examination. The labour will be handled according to definitions by Woman's department, Stavanger University Hospital, and WHO.
The use of stimulating agents, as Oxytocin, will be evaluated after manual examinations, specific definitions and criteria.
The results of the ultrasound examinations will be evaluated after the delivery, since the results are not to be used clinically during the delivery.
Inclusion criteria will be primigravidae, with one fetus, after the 37th week. Feta head presentation. Ruptured membranes, at least one hour before inclusion. Prolonged first stage according to WHO definitions. The target is to include 100 subjects.
Inter- and intraobserver variation will be evaluated with intraclass coefficients. We will analyze operative delivery with normal vaginal delivery. Also, two groups divided by the stage 0 will be evaluated with statistics analyzes.
Time to delivery will be evaluated with Kaplan Meier and Cox regression analyzes.
- Conditions
- Prolonged Labor
- Being tested
- Ultrasound examination
- Keywords
- Prolonged labor, Ultrasound, Caeserian section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examinationOther
Trans-abdominal and trans-perineal 3D ultrasound examination
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound examination | Women with prolonged Labour; Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation. Receives: Other: Ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound
Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.
Measured: during labor
Secondary outcomes (1)
Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)
Measured: 6 hours post determination of prolonged labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Prolonged LaborStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Erik Andreas Torkildsen, MD, Principal investigator, Helse Stavanger HFTorbjørn Moe Eggebø, MD, PhD, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915148
- Sponsor's protocol ID
- StaHF500804
- Status last verified
- Apr 2016
- First submitted
- 3 Jun 2009
- Last updated
- 26 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Eggebo TM, Heien C, Okland I, Gjessing LK, Romundstad P, Salvesen KA. Ultrasound assessment of fetal head-perineum distance before induction of labor. Ultrasound Obstet Gynecol. 2008 Aug;32(2):199-204. doi: 10.1002/uog.5360.
PubMed 18528923Eggebo TM, Heien C, Okland I, Gjessing LK, Smedvig E, Romundstad P, Salvesen KA. Prediction of labour and delivery by ascertaining the fetal head position with transabdominal ultrasound in pregnancies with prelabour rupture of membranes after 37 weeks. Ultraschall Med. 2008 Apr;29(2):179-83. doi: 10.1055/s-2007-963017. Epub 2007 Jun 28.
PubMed 17599279Eggebo TM, Gjessing LK, Heien C, Smedvig E, Okland I, Romundstad P, Salvesen KA. Prediction of labor and delivery by transperineal ultrasound in pregnancies with prelabor rupture of membranes at term. Ultrasound Obstet Gynecol. 2006 Apr;27(4):387-91. doi: 10.1002/uog.2744.
PubMed 16565994Barbera AF, Pombar X, Perugino G, Lezotte DC, Hobbins JC. A new method to assess fetal head descent in labor with transperineal ultrasound. Ultrasound Obstet Gynecol. 2009 Mar;33(3):313-9. doi: 10.1002/uog.6329.
PubMed 19248000Henrich W, Dudenhausen J, Fuchs I, Kamena A, Tutschek B. Intrapartum translabial ultrasound (ITU): sonographic landmarks and correlation with successful vacuum extraction. Ultrasound Obstet Gynecol. 2006 Nov;28(6):753-60. doi: 10.1002/uog.3848.
PubMed 17063455Torkildsen EA, Salvesen KA, Eggebo TM. Prediction of delivery mode with transperineal ultrasound in women with prolonged first stage of labor. Ultrasound Obstet Gynecol. 2011 Jun;37(6):702-8. doi: 10.1002/uog.8951. Epub 2011 May 3.
PubMed 21308837Tutschek B, Torkildsen EA, Eggebo TM. Comparison between ultrasound parameters and clinical examination to assess fetal head station in labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):425-9. doi: 10.1002/uog.12422. Epub 2013 Mar 14.
PubMed 23371409Torkildsen EA, Salvesen KA, Eggebo TM. Agreement between two- and three-dimensional transperineal ultrasound methods in assessing fetal head descent in the first stage of labor. Ultrasound Obstet Gynecol. 2012 Mar;39(3):310-5. doi: 10.1002/uog.9065.
PubMed 21630362
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Stage 3D-ultrasound During Prolonged Labour.
- ClinicalTrials.gov ID
- NCT00915148
- Acronym / sponsor ID
- StaHF500804
- Conditions
- Prolonged Labor
- Keywords
- Prolonged labor, Ultrasound, Caeserian section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- Nov 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Jun 2009 (estimated)
- Results
- Posted 26 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study is designed to correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically, the study will evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.
Detailed description
AIM:
To correlate findings on ultrasound with manual palpation, and to consider if delivery outcome can be predicted with help of ultrasound. Specifically evaluate the significance of fetal head level (descent) in the pelvis, measured with ultrasound.
Objective:
Labours have traditionally been evaluated by manuals methods of the "delivery helper" - midwives or doctor. There are many factors that will prolong labour such as malcontractions, disproportion of the birth canal and malpresentation/position. In about 20% of primigravidae, the first stage will last longer than 10 hours.
In this study we want to evaluate different ultrasounds measurements to see if ultrasound can be used to predict the outcome of labour.
Methods:
A descriptive observational study, with one ultrasound examination. The labour will be handled according to definitions by Woman's department, Stavanger University Hospital, and WHO.
The use of stimulating agents, as Oxytocin, will be evaluated after manual examinations, specific definitions and criteria.
The results of the ultrasound examinations will be evaluated after the delivery, since the results are not to be used clinically during the delivery.
Inclusion criteria will be primigravidae, with one fetus, after the 37th week. Feta head presentation. Ruptured membranes, at least one hour before inclusion. Prolonged first stage according to WHO definitions. The target is to include 100 subjects.
Inter- and intraobserver variation will be evaluated with intraclass coefficients. We will analyze operative delivery with normal vaginal delivery. Also, two groups divided by the stage 0 will be evaluated with statistics analyzes.
Time to delivery will be evaluated with Kaplan Meier and Cox regression analyzes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound examination | – | Other: Ultrasound examinationWomen with prolonged Labour; Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primi gravidae, with one fetus, after the 37th week. Cephalic presentation. Prolonged first stage according to WHO definitions.
Key inclusion criteria (4 listed)
- Primi gravidae
- >37th week
- Cephalic presentation
- Prolonged first stage according to WHO definitions.
Key exclusion criteria (2 listed)
- Multiple pregnancies
- Intrauterine fetal death
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 |
|---|---|---|
| Ultrasound examinationTrans-abdominal and trans-perineal 3D ultrasound examination | Other | Ultrasound examination |
Primary outcome
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound
Time frame: during labor
Fetal Head descent was first measured as the shortest distance between the outer bony limit of the fetal skull and the Perineum. Fetal head descent was re-assessed by measuring the angle of progression in a mid-sagittal plane. Fetal head-perineum distance was evaluated with using a cut-off of ≤40 mm, while the angle of progression was evaluated using a cut off of ≥ 110 degrees. The ROC curves plotted the percentage sensitivity against the percentage false positive rate for head-perineum distance and angle of progression as measured by ultrasound.
1 secondary outcome
Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations)
Time frame: 6 hours post determination of prolonged labor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18528923Eggebo TM, Heien C, Okland I, Gjessing LK, Romundstad P, Salvesen KA. Ultrasound assessment of fetal head-perineum distance before induction of labor. Ultrasound Obstet Gynecol. 2008 Aug;32(2):199-204. doi: 10.1002/uog.5360.
- Background: PubMed 17599279Eggebo TM, Heien C, Okland I, Gjessing LK, Smedvig E, Romundstad P, Salvesen KA. Prediction of labour and delivery by ascertaining the fetal head position with transabdominal ultrasound in pregnancies with prelabour rupture of membranes after 37 weeks. Ultraschall Med. 2008 Apr;29(2):179-83. doi: 10.1055/s-2007-963017. Epub 2007 Jun 28.
- Background: PubMed 16565994Eggebo TM, Gjessing LK, Heien C, Smedvig E, Okland I, Romundstad P, Salvesen KA. Prediction of labor and delivery by transperineal ultrasound in pregnancies with prelabor rupture of membranes at term. Ultrasound Obstet Gynecol. 2006 Apr;27(4):387-91. doi: 10.1002/uog.2744.
- Background: PubMed 19248000Barbera AF, Pombar X, Perugino G, Lezotte DC, Hobbins JC. A new method to assess fetal head descent in labor with transperineal ultrasound. Ultrasound Obstet Gynecol. 2009 Mar;33(3):313-9. doi: 10.1002/uog.6329.
- Background: PubMed 17063455Henrich W, Dudenhausen J, Fuchs I, Kamena A, Tutschek B. Intrapartum translabial ultrasound (ITU): sonographic landmarks and correlation with successful vacuum extraction. Ultrasound Obstet Gynecol. 2006 Nov;28(6):753-60. doi: 10.1002/uog.3848.
- Results publication: PubMed 21308837Torkildsen EA, Salvesen KA, Eggebo TM. Prediction of delivery mode with transperineal ultrasound in women with prolonged first stage of labor. Ultrasound Obstet Gynecol. 2011 Jun;37(6):702-8. doi: 10.1002/uog.8951. Epub 2011 May 3.
- Results publication: PubMed 23371409Tutschek B, Torkildsen EA, Eggebo TM. Comparison between ultrasound parameters and clinical examination to assess fetal head station in labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):425-9. doi: 10.1002/uog.12422. Epub 2013 Mar 14.
- Results publication: PubMed 21630362Torkildsen EA, Salvesen KA, Eggebo TM. Agreement between two- and three-dimensional transperineal ultrasound methods in assessing fetal head descent in the first stage of labor. Ultrasound Obstet Gynecol. 2012 Mar;39(3):310-5. doi: 10.1002/uog.9065.
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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.
Erik Andreas Torkildsen, MD principal investigator
Helse Stavanger HF
Torbjørn Moe Eggebø, MD, PhD study director
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prolonged Labor, run by Helse Stavanger HF 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 4 inclusion and 2 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 26 Apr 2016. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound (time frame: during labor). 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 NCT00915148, which also lists 8 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 26 Apr 2016.