Bluesky

Lateral episiotomy or no episiotomy in vacuum assisted delivery in nulliparous women (EVA): multicentre, open label, randomised controlled trial

Objective To assess the effect of lateral episiotomy, compared with no episiotomy, on obstetric anal sphincter injury in nulliparous women requiring vacuum extraction. Design A multicentre, open label, randomised controlled trial. Setting Eight hospitals in Sweden, 2017-23. Participants 717 nulliparous women with a single live fetus of 34 gestational weeks or more, requiring vacuum extraction were randomly assigned (1:1) to lateral episiotomy or no episiotomy using sealed opaque envelopes. Randomisation was stratified by study site. Intervention A standardised lateral episiotomy was performed during the vacuum extraction, at crowning of the fetal head, starting 1-3 cm from the posterior fourchette, at a 60° (45-80°) angle from the midline, and 4 cm (3-5 cm) long. The comparison was no episiotomy unless considered indispensable. Main outcome measures The primary outcome of the episiotomy in vacuum assisted delivery (EVA) trial was obstetric anal sphincter injury, clinically diagnosed by combined visual inspection and digital rectal and vaginal examination. The primary analysis used a modified intention-to-treat population that included all consenting women with attempted or successful vacuum extraction. As a result of an interim analysis at significance level P<0.01, the primary endpoint was tested at 4% significance level with accompanying 96% confidence interval (CI). Results From 1 July 2017 to 15 February 2023, 717 women were randomly assigned: 354 (49%) to lateral episiotomy and 363 (51%) to no episiotomy. Before vacuum extraction attempt, one woman withdrew consent and 14 had a spontaneous birth, leaving 702 for the primary analysis. In the intervention group, 21 (6%) of 344 women sustained obstetric anal sphincter injury, compared with 47 (13%) of 358 women in the comparison group (P=0.002). The risk difference was −7.0% (96% CI −11.7% to −2.5%). The risk ratio adjusted for site was 0.47 (96% CI 0.23 to 0.97) and unadjusted risk ratio was 0.46 (0.28 to 0.78). No significant differences were noted between groups in postpartum pain, blood loss, neonatal outcomes, or total adverse events, but the intervention group had more wound infections and dehiscence. Conclusions Lateral episiotomy can be recommended for nulliparous women requiring vacuum extraction to significantly reduce the risk of obstetric anal sphincter injury. Trial registration ClinicalTrials.gov [NCT02643108][1]. The study protocol and the statistical analysis plan is available with publication as supplementary material. Deidentified individual participant data and a data dictionary defining each field in the set will be made available to others for meta-analysis with investigator support after approval of a proposal (sophia.brismar-wendel{at}regionstockholm.se) and with a signed data access agreement. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02643108&atom=%2Fbmj%2F385%2Fbmj-2023-079014.atom

Digitaler Unterricht: Ignoriert die Erkenntnisse aus Schweden!

Warum die Debatte über digitalen Unterricht in Deutschland gerade in eine völlig falsche Richtung geht.

Gegen den Digitalisierungsstopp im Bildungswesen

Für eine schädliche Über-Digitalisierung gibt es in Deutschland kaum Anzeichen. Bildungsforscher:innen kritisieren einseitige Karolinska-Stellungnahme.

Antioxidants such as vitamin C found to spur cancer growth & metastasis

A new study has found that antioxidants like vitamins C and E activate a mechanism that stimulates the growth of new blood vessels in cancer tumors, helping them to grow and spread. The researchers say their findings highlight the potential risk of taking antioxidant supplements when they’re not…