Pregnancy rates among female participants in phase I and phase IIA AIDS vaccine clinical trials in Kenya.
East Afr Med J
; 86(9): 430-4, 2009 Sep.
Article
en En
| MEDLINE
| ID: mdl-21644413
ABSTRACT
BACKGROUND:
Female participants in AIDS candidate vaccine clinical trials must agree to use effective contraception to be enrolled into the studies, and for a specified period after vaccination, since the candidate vaccines' effects on the embryo or foetus are unknown.OBJECTIVES:
To review data on female participants' pregnancy rates from phase I and IIA AIDS vaccine clinical trials conducted at the Kenya AIDS Vaccine Initiative (KAVI) and to discuss the challenges of contraception among female participants.DESIGN:
Descriptive observational retrospective study.SETTING:
KAVI clinical trial site, Kenyatta National Hospital and University of Nairobi, Kenya.SUBJECTS:
Thirty nine female participants were enrolled into these trials. They received family planning counselling and were offered a choice of different contraceptive methods, as per the protocols. All contraception methods chosen by the participants were offered at the study site at no cost to the participant.RESULTS:
Four women conceived during the study period when pregnancies were to be avoided. All four had opted for sexual abstinence as a contraceptive method, but reported having been coerced by their partners to have unprotected sexual intercourse.CONCLUSION:
Abstinence is clearly not a reliable contraceptive option for women in developing-country settings. Effective female-controlled contraceptives, administered at the clinical trial site, may empower female participants to better control their fertility, leading to more complete clinical trial data.
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Banco de datos:
MEDLINE
Asunto principal:
Índice de Embarazo
/
Sujetos de Investigación
Tipo de estudio:
Guideline
/
Observational_studies
Límite:
Female
/
Humans
/
Pregnancy
País/Región como asunto:
Africa
Idioma:
En
Año:
2009
Tipo del documento:
Article