Prolonged Labor
Conditions
Keywords
Prolonged labor, Ultrasound, Caeserian section
Brief 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.
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.
Interventions
OTHERUltrasound examination
Trans-abdominal and trans-perineal 3D ultrasound examination
Sponsors
Helse Stavanger HF
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Primi gravidae * \>37th week * Cephalic presentation * Prolonged first stage according to WHO definitions.
Exclusion criteria
* Multiple pregnancies * Intrauterine fetal death
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) | 6 hours post determination of prolonged labor |
Countries
Norway
Participant flow
Recruitment details
Medical contact during10 months
Pre-assignment details
No participants were excluded
Participants by arm
| Arm | Count |
|---|---|
| Women With Prolonged Labour Primi gravidae, single pregnancy, \>37 weeks, fetus alive, cephalic presentation.
Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Women With Prolonged Labour |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 110 Participants |
| Age, Continuous | 29 years |
| Region of Enrollment Norway | 110 participants |
| Sex: Female, Male Female | 110 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
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.
Time frame: during labor
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With Prolonged Labour | Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound | 2D fetal head-perineum distance (AUC) | 81 percentage probability |
| Women With Prolonged Labour | Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound | 2D angle of progression (AUC) | 76 percentage probability |
| Women With Prolonged Labour | Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound | 3D fetal head-perineum distance | 80 percentage probability |
| Women With Prolonged Labour | Area Under the Receiver Operating Curve (ROC AUC) Values for Prediction of Vaginal Delivery Using 2D or 3D Ulrasound | 3D angle of progression (AUC) | 76 percentage probability |
Comparison: In a previous study we investigated women before induction of labor. Using 40 mm as cut-off level for fetal head - perineum distance, the Cesarean section rate in primiparous women was 7% in the group with a short distance and 27% in the group with a long distance. We assumed similar results, with alpha 0.05, power 0.8 and a ratio of 1 : 1 for the numbers of women with a long and short distance. We would need to include 110 women in the study.p-value: <0.01Chi-squared
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Women With Prolonged Labour | Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) | Fetal head-perineum distance ≤40 mm (n=54) | 74 percentage of participants |
| Women With Prolonged Labour | Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) | Fetal head-perineum distance >40 mm (n=56) | 39 percentage of participants |
| Women With Prolonged Labour | Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) | Angle of progression ≥110 degrees (n=53) | 72 percentage of participants |
| Women With Prolonged Labour | Percentage of Women With Delivery Within 6 Hours From Defined Prolonged Labor (in Accordance With WHO Recommendations) | Angle of progression <110 degrees (n=57) | 44 percentage of participants |
Comparison: Kaplan Meier plots were used to compare time from a defined prolonged labor in the first stage to delivery for~1. women with fetal head-perineum distance ≤40 mm vs. women with distance \>40 mm measured with 2D ultrasound.~2. women with angle of progression ≥110 degrees vs. women with angle \<110 degrees measured with 2D ultrasoundp-value: <0.01Log Rank