Study of Ultrasound Imaging to Predict Time and Outcome in Pregnancies With Induced Labor
Study Details
Study Description
Brief Summary
The aim of the study was to evaluate any possible associations between engagement and position of the fetal head and the outcome of labor in women with induced labor, and to compare the value of ultrasound measurements in predicting the time from induction to delivery and operative deliveries.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
Fetal head engagement measured by ultrasound as a predictive factor of labor outcome in women with induced labor
- EGGEBØ, L. K. GJESSING, I. ØKLAND, C. HEIEN, P. ROMUNDSTAD*, K. Å. SALVESEN** Department of Obstetrics and Gynaecology, Stavanger University Hospital, Norway * Department of Public Health, NTNU, Norway, St Olavs Hospital, Trondheim University Hospital
** National Center for Fetal Medicine, Department of Obstetrics and Gynaecology, Trondheim University Hospital (St. Olav's Hospital) and Department of Laboratory Medicine, Children's and Women's Health, Norwegian University of Science and Technology
KEYWORDS:
Ultrasound, induced labor, cervical length, engagement of fetal head, occiput posterior, Bishop score, outcome of labor
Objective The aim of the study is to evaluate any possible associations between engagement of the fetal head, the cervical status or occiput posterior position and the outcome of labor in women with induced labor, and to compare the value of ultrasound measurements with Bishop score in predicting operative deliveries.
Methods The ultrasound examinations will be carried out in 275 women immediately before induction of labor. A transabdominal scan will be performed to determine the position of the fetal occiput, a transperineal scan with transverse view to determine the degree of engagement and a transvaginal examination to evaluate the cervical length and the cervical angle.. The Bishop score will be performed by another examinator who is blinded to the results of the ultrasound examinations. The time from induction to delivery will be tested in a Cox regression analysis with fetal head engagement, cervical length and parity as possible predictive factors and maternal age, BMI, gestational age, birth weight and head circumference as possible confounders.
Inclusion and exclusion criteria:
Women were eligible for the study if they had a live singleton pregnancy with cephalic presentation and a gestational age of more than 37 completed pregnancy weeks according to a mid-trimester scan.
Statistical analysis Appropriate statistical tests for comparisons, such as Mann Whitney U test, chi-square test, Fisher's exact test, Pearson correlation, Kaplan Meier survival analysis and Cox regression analysis will be used. For receiver-operating characteristics (ROC) curves, the area under the curve will be used as discriminator. P-values < 0.05 will be considered significant.
Study Design
Outcome Measures
Primary Outcome Measures
- Vaginal Delivery in Induced Labors [Time from induction of labor to delivery]
The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head-perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum.
Secondary Outcome Measures
- Delivery Within 24 Hours [Time from induction to delivery]
Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Pregnancy
-
Indication of induced labor
Exclusion Criteria:
-
More than one fetus
-
Less than 37 weeks of pregnancy
-
Previous cesarean section
-
Breach position
-
Dead fetus
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stavanger University Hospital | Stavanger | Norway | NO-4011 |
Sponsors and Collaborators
- Helse Stavanger HF
- Norwegian University of Science and Technology
- St. Olavs Hospital
Investigators
- Study Director: Kjell Å. Salvesen, Prof. PhD, St. Olavs Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- BISHOP EH. PELVIC SCORING FOR ELECTIVE INDUCTION. Obstet Gynecol. 1964 Aug;24:266-8.
- Dietz HP, Lanzarone V, Simpson JM. Predicting operative delivery. Ultrasound Obstet Gynecol. 2006 Apr;27(4):409-15.
- Eggebø TM, Gjessing LK, Heien C, Smedvig E, Økland 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.
- Eggebø TM, Heien C, Økland 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.
- Eggebø TM, Økland I, Heien C, Gjessing LK, Romundstad P, Salvesen KA. Can ultrasound measurements replace digitally assessed elements of the Bishop score? Acta Obstet Gynecol Scand. 2009;88(3):325-31. doi: 10.1080/00016340902730417.
- Rane SM, Guirgis RR, Higgins B, Nicolaides KH. The value of ultrasound in the prediction of successful induction of labor. Ultrasound Obstet Gynecol. 2004 Oct;24(5):538-49.
- StaHF483201
- Helse Vest 911314
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Successful Vaginal Delivery |
|---|---|
| Arm/Group Description | 275 women with induced labors were included in the study, and the main outcome was vaginal delivery. Variables associated to a successful vaginal delivery was examined. |
| Period Title: Overall Study | |
| STARTED | 275 |
| COMPLETED | 275 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Time From Induction to Delivery |
|---|---|
| Arm/Group Description | Variables associated to time from induction to delivery were investigated. |
| Overall Participants | 275 |
| Age (Count of Participants) | |
| <=18 years |
3
1.1%
|
| Between 18 and 65 years |
272
98.9%
|
| >=65 years |
0
0%
|
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
30
|
| Sex: Female, Male (Count of Participants) | |
| Female |
275
100%
|
| Male |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| Norway |
275
100%
|
Outcome Measures
| Title | Vaginal Delivery in Induced Labors |
|---|---|
| Description | The association between Bishop score, ultrasound assessed fetal station, ultrasound assessed cervical length, cervical posterior angle and a vaginal delivery was investigated using area under the ROC curves. Fetal station was assessed by ultrasound as the fetal head-perineum distance (HPD); which was measured by transperineal ultrasound imaging as the shortest distance from the outer bony limit of the fetal skull to the skin surface of the perineum. |
| Time Frame | Time from induction of labor to delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Successful Vaginal Delivery |
|---|---|
| Arm/Group Description | 275 women with induced labors were included in the study, and the main outcome was vaginal delivery. Variables associated to a successful vaginal delivery was examined. |
| Measure Participants | 275 |
| Area under the ROC curve associated to HPD |
62
|
| Area under the curve associated to cervical length |
61
|
| Area under the curve associated to cervical angle |
63
|
| Area under the curve associated to Bishop score |
60
|
| Title | Delivery Within 24 Hours |
|---|---|
| Description | Association between parity, HPD, cervical length, cervical angle, occiput posterior position, parity, BMI and the Hazard ratio of delivering within 24 hours was investigated using Cox regression analysis. |
| Time Frame | Time from induction to delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| Hazard ratio was reported. |
| Arm/Group Title | Time From Induction to Delivery |
|---|---|
| Arm/Group Description | Variables associated to time from induction to delivery were investigated. |
| Measure Participants | 275 |
| HPD ≤ 40 mm |
1.67
|
| Cervical length ≤ 25 mm |
2.35
|
| Cervical posterior > 90 degrees |
1.92
|
| Occiput posterior position |
1.27
|
| Multiparous woman |
3.25
|
| BMI < 30 |
1.14
|
Adverse Events
| Time Frame | From start of induction to discharge from the labor ward | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Successful Vaginal Delivery | |
| Arm/Group Description | 275 women with induced labors were included in the study, and the main outcome was vaginal delivery. Variables associated to a successful vaginal delivery was examined. | |
All Cause Mortality |
||
| Successful Vaginal Delivery | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Successful Vaginal Delivery | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/275 (0.4%) | |
| Cardiac disorders | ||
| maternal death | 1/275 (0.4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Successful Vaginal Delivery | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/275 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Professor Torbjørn Moe Eggebø |
|---|---|
| Organization | Stavanger University Hospital |
| Phone | +4792699433 |
| tme@lyse.net |
- StaHF483201
- Helse Vest 911314