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Avoiding sexual intercourse in late pregnancy and the risk of Group B Streptococcus carriage in the mother

Sexual intercourse abstinence and ano-vaginal Group B Streptococcus carriage in late pregnancy: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12028526
Enrollment
270
Registered
2026-01-30
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maternal Group B Streptococcus carriage at 35-37 weeks of pregnancy. Pregnancy and Childbirth

Interventions

Randomization will be conducted using a computerized sequence generator. The sequence will be generated in random blocks of 4 or 8 (1:1 ratio) via https://www.sealedenvelope.com/simple-randomiser/v1/l

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. 32-34 weeks gestation. 2. Adult (18 years old and above) 3. Singleton pregnancy 4. Live fetus 5. Sexually active (vaginal sex at least once a week in the last week) 6. Partner's agreement for participation and recording of sexual activity information in the study

Exclusion criteria

Exclusion criteria: 1. Culture proven GBS colonization or infection (from any site) in current pregnancy 2. Antibiotics use in the last 4 weeks (any indication) 3. Preterm prelabour rupture of membrane 4. Significant medical/antenatal complications (cardiac disease, renal disease, recurrent vaginal bleeding in pregnancy, etc) 5. Proven/suspected vaginal infection in the last 4 weeks 6. Contraindication to sexual intercourse (placenta praevia, current vaginal bleeding, etc)

Countries

Malaysia

Contacts

Public ContactWong Thai Ying
thai.wong@um.edu.my+60169459213

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026