Vermessung des Beckens (Pelvimetrie) bei Kopflage nahe dem oder am Geburtstermin zur Entscheidung über die Entbindungsmethode
Referencias
References to studies included in this review
References to studies excluded from this review
Additional references
References to other published versions of this review
Characteristics of studies
Characteristics of included studies [ordered by study ID]
Ir a:
| Study characteristics | ||
| Methods | Prospective randomised controlled trial in a hospital setting. 2 treatment arms. | |
| Participants | 305 labouring women randomised whose attending doctors requested pelvimetry by radiography. | |
| Interventions | Intervention group: 151 women allocated to intrapartum x‐ray pelvimetry when requested by staff. Comparison group: 154 women allocated to no pelvimetry when requested by staff. | |
| Outcomes |
| |
| Notes | No electronic fetal heart rate monitoring used. No information on the indication for X‐ray pelvimetry except that the doctor wished to have it performed on a woman in labour. No blinding of staff, this could possibly affect results if staff requesting pelvimetry are not able to use it. Hospital setting in country not explicitly named but likely to be South Africa. Funding source: not stated. Dates study was conducted: unclear Declarations of interest of primary researchers: unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Intrapartum radiography‐when desired by staff‐would only be permitted if an envelope removed front the box contained permission typed "yes" as opposed to the refusal typed "no". Obviously no exceptions were permitted this rule." |
| Allocation concealment (selection bias) | Unclear risk | No mention in text. |
| Blinding of participants and personnel (performance bias) | High risk | Called "double‐blind" but no further details are given. Staff would have been aware of whether or not pelvimetry was permitted, women may not have been told. Clinical management may have been affected by knowledge of allocation. |
| Blinding of outcome assessment (detection bias) | High risk | Assessment of some of the outcomes (e.g. neonatal well‐being) may have been affected by lack of blinding. Assessment may have been by staff aware of allocation. |
| Incomplete outcome data (attrition bias) | Low risk | Appears complete. |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available, outcomes not pre‐specified in methods. |
| Other bias | Unclear risk | No other bias apparent but baseline characteristics of participants not reported. |
| Study characteristics | ||
| Methods | Prospective 2‐armed randomised controlled trial. | |
| Participants | 264 women randomised. Inclusion criteria: Pregnant nulliparous women Aged between 20‐35 ≥ 37 weeks' gestation Normal placental function With a medical indication for induction of labour Exclusion criteria: Multiple birth pregnancies Breech position | |
| Interventions | Intervention group: 133 women, X‐ray pelvimetry before their induction according to the Bedoya technique. Control/comparison group: 131 women, not given X‐ray pelvimetry before their induction. | |
| Outcomes | 1. Time taken from induction to expulsion or extraction of the fetus 2. Method of extraction (labour or caesarean) 3. Use of instruments during the birth (forceps etc.) 4. Any secondary/adverse effects 5. Perinatal mortality | |
| Notes | Conducted at the unit of clinical management, University Hospital Virgen Macarena in Seville, Spain. Funding source: not stated. Dates study was conducted: unclear Declarations of interest of primary researchers: unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | 264 women were chosen in strict chronological order and were distributed into 2 groups according to a random number table. |
| Allocation concealment (selection bias) | Unclear risk | The random number table was only known by the head researcher in charge of recruitment, the doctor responsible for inductions and the only person who was authorised to take clinical decisions in relation to the use of the X‐ray pelvimetry, which was always evaluated before proceeding with the induction of labour. |
| Blinding of participants and personnel (performance bias) | High risk | "All women who underwent X‐PM were informed of the process in detail and were only included in the study if they gave their consent." Following the induction, the medical staff working during the labour (obstetric surgeons and midwives) were not aware if the woman had undergone X‐ray pelvimetry. Although there was an attempt to blind some staff, women were aware of the pelvimetry. It is likely this blinding could have been broken. |
| Blinding of outcome assessment (detection bias) | High risk | As blinding of staff is not convincing, some outcomes may have been affected by the lack of blinding. |
| Incomplete outcome data (attrition bias) | Low risk | Appears complete. |
| Selective reporting (reporting bias) | Unclear risk | Not all outcomes are mentioned‐ unclear if this is due to translation. |
| Other bias | Unclear risk | In text of study it says that 21 caesarean sections were done in each group but the table data shows different, higher numbers. |
| Study characteristics | ||
| Methods | Prospective randomised study at the University of Illinois Hospital, Chicago. Women individually randomised by hospital number. 2 treatment arms. | |
| Participants | 200 women randomised when admitted to hospital for induction or augmentation of labour using oxytocin. Inclusion criteria: primigravida with vertex presentation. | |
| Interventions | Intervention group: 102 women allocated to receive clinical and X‐ray pelvimetry before induction or augmentation. Comparison group: 98 women allocated to receive no X‐ray pelvimetry before induction or augmentation. This group all received clinical pelvimetry. | |
| Outcomes |
| |
| Notes | All women monitored with electronic fetal heart rate monitoring and intrauterine pressure monitors. Funding source: not stated. Dates study was conducted: unclear Declarations of interest of primary researchers: unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "Patients were randomised into two groups by hospital number." |
| Allocation concealment (selection bias) | High risk | Randomisation by hospital number means that staff recruiting women to the study may have been able to anticipate randomisation group. |
| Blinding of participants and personnel (performance bias) | High risk | Blinding of patients is not likely with this intervention. "The management of all patients then proceeded on the basis of clinical and/or x‐ray evaluation, and the investigators did not participate in the evaluation of the pelvises in the management plan." Does not appear staff were blinded which could have affected treatment of both intervention and comparison groups. |
| Blinding of outcome assessment (detection bias) | High risk | The recording of outcomes was by a member of staff caring for the patient who would be aware of randomisation group. It was stated that the investigators did not participate in the evaluation of pelvises but all other clinical staff would be aware of the intervention. |
| Incomplete outcome data (attrition bias) | Low risk | Appears complete, reports outcomes for all participants. |
| Selective reporting (reporting bias) | Unclear risk | No protocol but outcomes stated in methods section. Length of labour data reported narratively, no actual data. |
| Other bias | Low risk | No baseline imbalance reported. No other bias apparent. |
| Study characteristics | ||
| Methods | Prospective randomised controlled trial. Women individually randomised. 2 treatment arms. | |
| Participants | 102 women randomised. Inclusion criteria: pregnant women with 1 previous caesarean section. Exclusion criteria: previous caesarean section used a classical uterine incision | |
| Interventions | Intervention group: 52 women allocated to receive X‐ray pelvimetry at 36 weeks' gestation. If the pelvic inlet was < 10.5 cm in the antero‐posterior diameter or < 11. 5 cm in the transverse diameter, an elective caesarean section was performed. A trial of scar was performed on the rest. Comparison group: 50 women allocated to no antenatal pelvimetry and all women had a trial of scar. Spontaneous labour was awaited. X‐ray pelvimetry was performed postpartum. | |
| Outcomes | 1. Mode of delivery 2. Pelvimetry measurements 3. Birthweight 4. Average stay in hospital | |
| Notes | 2 stillbirths occurred in the control prior to the onset of labour, both were thought to be due to post maturity. Both scar dehiscences were diagnosed by bimanual examination following normal vaginal deliveries, and repaired by laparotomy without any further complication. Trial took place at King Edward VIII Hospital, Durban. Funding source: not stated. Dates study was conducted: unclear Declarations of interest of primary researchers: unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Randomly allocated to two groups." No further information given. |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
| Blinding of participants and personnel (performance bias) | High risk | No blinding. Knowledge of treatment group may have affected clinical treatment. |
| Blinding of outcome assessment (detection bias) | High risk | Some of the outcomes may have been affected by lack of blinding. |
| Incomplete outcome data (attrition bias) | Unclear risk | Denominators not given in results tables. |
| Selective reporting (reporting bias) | Unclear risk | Outcomes not prespecified in text. |
| Other bias | Unclear risk | No other bias apparent. |
| Study characteristics | ||
| Methods | Prospective randomised controlled trial. Women individually randomised. 2 treatment arms. | |
| Participants | 288 women randomised. Inclusion criteria: women with 1 previous transverse lower segment caesarean section. Exclusion criteria: ‐ abnormal lie or presentation; ‐ obstetric complications requiring planned delivery; ‐ maternal disorders contra‐indicating a trial of scar; ‐ multiple pregnancy; ‐ preterm labour; ‐ grossly contracted pelvis on clinical examination; ‐ intrauterine death. | |
| Interventions | Intervention group: 144 women allocated to x‐ray pelvimetry group at 36 weeks. A sagittal inlet < 11 cm, sagittal outlet < 10 cm, transverse inlet < 11.5 cm, and transverse outlet (bispinous) < 9 cm was an indication for caesarean section. The remainder of the group awaited spontaneous labour and underwent a 'trial of scar’. Comparison group: 144 women had no pelvimetry at 36 weeks and awaited spontaneous labour. | |
| Outcomes |
| |
| Notes | 153 women were randomised to either group. In the study group, 1 withdrew consent, 2 had breech presentations, 2 had twin pregnancies, 2 had hypertension and 2 developed preterm labour. In the control group 3 elected to have an elective caesarean section, 2 had breech presentations, 1 twin gestation, 2 hypertensives and 1 preterm labour. Each group consisted finally of 144 women. Analysis was on the last number and not according to intention to treat. 6 women had scar dehiscences, 2 diagnosed in labour (control group) and 4 on routine digital examination after delivery. None of the women required hysterectomy or had postpartum haemorrhage. Trial took place at King Edward VIII Hospital, Durban. Funding source: not stated. Dates study was conducted: randomisation occurred "during the second half of 1990", primary outcome follow‐up completed February 1991 Declarations of interest of primary researchers: unclear | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "Randomisation and equal distribution were assured because women were allocated alternately to the two teams by admitting clerks who had no medical training and no knowledge of how they would be managed." |
| Allocation concealment (selection bias) | High risk | Not mentioned but a different medical team provided the intervention and control care therefore no concealment attempted. |
| Blinding of participants and personnel (performance bias) | High risk | Not mentioned. Difficult to blind this type of intervention. |
| Blinding of outcome assessment (detection bias) | High risk | Management of care and outcome recording was done by different teams of staff for women in the 2 groups. This means outcomes may not have been measured and recorded in the same way. |
| Incomplete outcome data (attrition bias) | Unclear risk | 306 women randomised. 288 followed up ‐ loss was relatively low but loss of 2 women in the pelvimetry group related to outcomes (women opted for caesarean section). |
| Selective reporting (reporting bias) | Unclear risk | Outcomes not mentioned in methods text, protocol not available. |
| Other bias | Low risk | Baseline characteristics appeared similar. Other bias not apparent. |
Characteristics of excluded studies [ordered by study ID]
Ir a:
| Study | Reason for exclusion |
| Trial was stopped prior to completion as randomisation not adequate. There were too few women recruited and study protocol was not adhered to. |
Data and analyses
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Caesarean section Show forest plot | 5 | 1159 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.34 [1.19, 1.52] |
| Analysis 1.1  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 1: Caesarean section | ||||
| 1.1.1 No previous caesarean section | 3 | 769 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.24 [1.02, 1.52] |
| 1.1.2 Previous caesarean section | 2 | 390 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.45 [1.26, 1.67] |
| 1.2 Perinatal mortality Show forest plot | 5 | 1159 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.53 [0.19, 1.45] |
| Analysis 1.2  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 2: Perinatal mortality | ||||
| 1.2.1 No previous caesarean section | 3 | 769 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.21, 1.90] |
| 1.2.2 Previous caesarean section | 2 | 390 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.19 [0.01, 3.91] |
| 1.3 Puerperal pyrexia Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.22, 2.92] |
| Analysis 1.3  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 3: Puerperal pyrexia | ||||
| 1.3.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.3.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.22, 2.92] |
| 1.4 Wound sepsis Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.26, 2.67] |
| Analysis 1.4  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 4: Wound sepsis | ||||
| 1.4.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.4.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.26, 2.67] |
| 1.5 Blood transfusion Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.39, 2.59] |
| Analysis 1.5  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 5: Blood transfusion | ||||
| 1.5.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.5.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.39, 2.59] |
| 1.6 Scar dehiscence Show forest plot | 2 | 390 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.59 [0.14, 2.46] |
| Analysis 1.6  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 6: Scar dehiscence | ||||
| 1.7 Perinatal asphyxia Show forest plot | 1 | 305 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.66 [0.39, 1.10] |
| Analysis 1.7  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 7: Perinatal asphyxia | ||||
| 1.8 Admission to special care baby units Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.20 [0.01, 4.13] |
| Analysis 1.8  Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 8: Admission to special care baby units | ||||
| 1.8.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.8.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.20 [0.01, 4.13] |
Study flow diagram.
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 1: Caesarean section
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 2: Perinatal mortality
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 3: Puerperal pyrexia
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 4: Wound sepsis
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 5: Blood transfusion
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 6: Scar dehiscence
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 7: Perinatal asphyxia
Comparison 1: X‐ray pelvimetry versus no X‐ray pelvimetry, Outcome 8: Admission to special care baby units
| X‐ray pelvimetry compared to no X‐ray pelvimetry in fetal cephalic presentations at or near term | ||||||
| Patient or population: pregnant women at or near term with fetal cephalic presentations | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect | № of participants | Quality of the evidence | Comments | |
|---|---|---|---|---|---|---|
| Risk with no pelvimetry in cephalic presentations | Risk with X‐ray pelvimetry | |||||
| Caesarean section | Study population | RR 1.34 | 1159 | ⊕⊕⊝⊝ | One study Crichton 1962 reported caesarean section and symphysiotomy together | |
| 388 per 1000 | 520 per 1000 | |||||
| Perinatal mortality | Study population | RR 0.53 | 1159 | ⊕⊝⊝⊝ | ||
| 17 per 1000 | 9 per 1000 | |||||
| Wound sepsis | Study population | RR 0.83 | 288 | ⊕⊝⊝⊝ | ||
| 42 per 1000 | 35 per 1000 | |||||
| Blood transfusion | Study population | RR 1.00 | 288 | ⊕⊝⊝⊝ | ||
| 56 per 1000 | 56 per 1000 | |||||
| Scar dehiscence | Study population | RR 0.59 | 390 | ⊕⊝⊝⊝ | ||
| 26 per 1000 | 15 per 1000 | |||||
| Admission to special care baby units | Study population | RR 0.20 | 288 | ⊕⊝⊝⊝ | ||
| 14 per 1000 | 3 per 1000 | |||||
| Apgar score < 7 at 5 minutes | Study population | ‐ | (0 studies) | ‐ | No data reported for this outcome | |
| see comment | see comment | |||||
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Most studies contributing data had design limitations. Two studies had serious design limitations (high risk of bias for sequence generation and allocation concealment) one of which contributed 37.4% of weight (‐2). 2 Most studies contributing data had design limitations. (‐1) 3 Wide confidence interval crossing the line of no effect, small sample size, few events and lack of precision. (‐2) 4 One study contributing data with serious design limitations. (‐2) 5 Very wide confidence intervals crossing the line of no effect, small sample size and few events. (‐2) 6 Study contributing 79.7% total weight has serious design limitations. (‐2) | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1.1 Caesarean section Show forest plot | 5 | 1159 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.34 [1.19, 1.52] |
| 1.1.1 No previous caesarean section | 3 | 769 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.24 [1.02, 1.52] |
| 1.1.2 Previous caesarean section | 2 | 390 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.45 [1.26, 1.67] |
| 1.2 Perinatal mortality Show forest plot | 5 | 1159 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.53 [0.19, 1.45] |
| 1.2.1 No previous caesarean section | 3 | 769 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.64 [0.21, 1.90] |
| 1.2.2 Previous caesarean section | 2 | 390 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.19 [0.01, 3.91] |
| 1.3 Puerperal pyrexia Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.22, 2.92] |
| 1.3.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.3.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.80 [0.22, 2.92] |
| 1.4 Wound sepsis Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.26, 2.67] |
| 1.4.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.4.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.83 [0.26, 2.67] |
| 1.5 Blood transfusion Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.39, 2.59] |
| 1.5.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.5.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 1.00 [0.39, 2.59] |
| 1.6 Scar dehiscence Show forest plot | 2 | 390 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.59 [0.14, 2.46] |
| 1.7 Perinatal asphyxia Show forest plot | 1 | 305 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.66 [0.39, 1.10] |
| 1.8 Admission to special care baby units Show forest plot | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.20 [0.01, 4.13] |
| 1.8.1 No previous caesarean section | 0 | 0 | Risk Ratio (M‐H, Fixed, 95% CI) | Not estimable |
| 1.8.2 Previous caesarean section | 1 | 288 | Risk Ratio (M‐H, Fixed, 95% CI) | 0.20 [0.01, 4.13] |
