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Updated: May 24, 2026
09:04
Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
Published on: September 10, 2018
Contraception and pregnancy in microbicide trials
Sengeziwe Sibeko1, Gabriel M Cohen, Jagidesa Moodley
1Centre for the AIDS Programme of Research in South Africa, 2nd Floor Doris Duke Medical Research Institute, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Private Bag X7, Congella, 4013, Durban, South Africa. sengeziwe.sibeko@ndm.ox.ac.uk
Summary
Young women in Sub-Saharan Africa face a high burden from the human immunodeficiency virus (HIV) epidemic. Effective contraceptive and pregnancy management programs are crucial for microbicide trials to ensure participant safety and trial integrity.
Area of Science:
- Reproductive Health
- Infectious Diseases
- Clinical Trials
Background:
- The human immunodeficiency virus (HIV) epidemic disproportionately affects women in Sub-Saharan Africa, particularly young women of reproductive age.
- High fertility rates in this region necessitate careful consideration in microbicide clinical trials.
Purpose of the Study:
- To address the challenges posed by high pregnancy rates in late-phase microbicide clinical trials conducted in Sub-Saharan Africa.
- To ensure the safety of unborn babies and maintain the statistical integrity of trials involving investigational drugs with unknown teratogenic potential.
Main Methods:
- Focus on implementing effective contraceptive and pregnancy management programs within microbicide trials.
- Strategies to maintain low pregnancy rates among trial participants.
Main Results:
- Pregnancy during trials can lead to drug withdrawal, potentially compromising study integrity.
- High pregnancy rates may impact the statistical power and validity of trial outcomes.
Conclusions:
- Effective contraceptive and pregnancy management are imperative for microbicide trials in high-fertility settings.
- These programs are essential to protect both the participants' unborn babies and the overall scientific integrity of the research.
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