Althuisius 2003.
| Methods | RCT ‐ block randomisation. July 1995 to July 2000. University Hospital Vrije Universiteit and Olze Lieve Vrouwe Gastus, Amsterdam. This trial recruited women alongside Althuisius 2001 and reported identical methodology |
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| Participants | Women were recruited at the same time as for Althuisius 2001. For Althuisius 2003, all women were < 27 weeks' gestation and had imminent preterm birth due to cervical incompetence with membranes bulging at or beyond the cervical os. Women were evaluated for trial entry with transvaginal ultrasound and an additional speculum examination when cervical length < 25 mm. Exclusion criteria: signs of infection including fever, uterine tenderness, fetal tachycardia, leukocytosis, and/or elevated C‐reactive protein |
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| Interventions |
Emergency cerclage (N = 13, 10 singleton and 3 twins): Emergency cerclage (MacDonald) and indomethacin 100 mg suppository 2 hours before and 6 hours after the operation Bed rest (N = 10, 6 singleton and 4 twins) Women in both arms received amoxicillin/clavulanic acid 1 g intravenously every 6 hours and metronidazole 500 mg intravenously every 8 hours for 1 week. All women remained hospitalised and on bed rest until 30 weeks' gestation. Cerclage removed on indication or at 37 weeks' gestation. One woman had membranes rupture during cerclage placement and the intervention was abandoned |
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| Outcomes | Preterm delivery at < 34 weeks of gestation, compound neonatal morbidity (defined as admission to the neonatal intensive care unit and/or neonatal death), and neonatal survival. We did not include deaths in the review outcome of 'neonatal morbidity' |
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| Notes | Data from this trial were not included in previous versions of this review. We included women reported here in the 'physical‐exam indicated' subgroup | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Sequence generation not described |
| Allocation concealment (selection bias) | Low risk | Telephone allocation |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated if outcomes assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis. No losses to follow‐up |
| Selective reporting (reporting bias) | Low risk | Stated outcomes are reported |
| Other bias | Unclear risk | Demographics at baseline comparable |