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Titolo:
Post-marketing surveillance of Norplant (R) contraceptive implants: II. Non-reproductive health
Autore:
Farley, TMM; Sivin, I;
Indirizzi:
WHO, CH-1211 Geneva, Switzerland WHO Geneva Switzerland CH-1211WHO, CH-1211 Geneva, Switzerland Populat Council, New York, NY 10021 USA Populat Council New York NY USA 10021 lat Council, New York, NY 10021 USA Bangladesh Fertil Res Program, Dhaka, Bangladesh Bangladesh Fertil Res Program Dhaka Bangladesh ogram, Dhaka, Bangladesh Bangladesh Assoc Voluntary Sterilizat, Khulna, Bangladesh Bangladesh AssocVoluntary Sterilizat Khulna Bangladesh lna, Bangladesh Family Planning Assoc Bangladesh, Khulna, Bangladesh Family Planning AssocBangladesh Khulna Bangladesh , Khulna, Bangladesh Mohammadpur Fertil Serv & Training Ctr, Dhaka, Bangladesh Mohammadpur Fertil Serv & Training Ctr Dhaka Bangladesh aka, Bangladesh Beijing Municipal Res Inst Family Planning, Beijing, Peoples R China Beijing Municipal Res Inst Family Planning Beijing Peoples R China hina Shanghai Med Univ, Shanghai 200032, Peoples R China Shanghai Med Univ Shanghai Peoples R China 200032 00032, Peoples R China Beijing Municipal Res Inst Family Planning, Beijing, Peoples R China Beijing Municipal Res Inst Family Planning Beijing Peoples R China hina Hunan Province Res Inst Family Planning, Changsha, Peoples R China Hunan Province Res Inst Family Planning Changsha Peoples R China China Chongqing Family Planning Serv Ctr, Chongqing, Peoples R China Chongqing Family Planning Serv Ctr Chongqing Peoples R China es R China Guizhou Province Res Inst Family Planning, Guiyang, Peoples R China Guizhou Province Res Inst Family Planning Guiyang Peoples R China China Shandong Provincial Res Inst Family Planning, Jinan, Peoples R China Shandong Provincial Res Inst Family Planning Jinan Peoples R China hina Shanghai Inst Planned Parenthood Res, Shanghai, Peoples R China Shanghai Inst Planned Parenthood Res Shanghai Peoples R China s R China Laoning Province Res Inst Family Planning, Shenyang, Peoples R China Laoning Province Res Inst Family Planning Shenyang Peoples R China hina Second Teaching Hosp, Tianjin Med Coll, Tianjin, Peoples R China Second Teaching Hosp Tianjin Peoples R China , Tianjin, Peoples R China Henan Province Res Inst Family Planning, Zhengzhou, Peoples R China Henan Province Res Inst Family Planning Zhengzhou Peoples R China China Inst Chileno Med Reprod, Santiago, Chile Inst Chileno Med Reprod Santiago Chile leno Med Reprod, Santiago, Chile Hosp Clin San Borja Arriaran, Santiago, Chile Hosp Clin San Borja Arriaran Santiago Chile a Arriaran, Santiago, Chile Sonia Pizarro Hosp Clin San Borja Arriaran, Santiago, Chile Sonia Pizarro Hosp Clin San Borja Arriaran Santiago Chile ntiago, Chile Profamilia, Bogota, Colombia Profamilia Bogota ColombiaProfamilia, Bogota, Colombia Profamilia, Cali, Colombia Profamilia Cali ColombiaProfamilia, Cali, Colombia Profamilia, Medellin, Colombia Profamilia Medellin ColombiaProfamilia, Medellin, Colombia Egyptian Fertil Care Soc, Cairo, Egypt Egyptian Fertil Care Soc Cairo Egypt tian Fertil Care Soc, Cairo, Egypt Ain Shams Univ, Cairo, Egypt Ain Shams Univ Cairo EgyptAin Shams Univ, Cairo, Egypt Univ Alexandria, Alexandria, Egypt Univ Alexandria Alexandria EgyptUniv Alexandria, Alexandria, Egypt Assiut Univ, Assiut 71516, Egypt Assiut Univ Assiut Egypt 71516Assiut Univ, Assiut 71516, Egypt Mansoura Univ, Mansoura 35516, Egypt Mansoura Univ Mansoura Egypt 35516Mansoura Univ, Mansoura 35516, Egypt Al Azhar Univ, Cairo, Egypt Al Azhar Univ Cairo EgyptAl Azhar Univ, Cairo, Egypt Univ Indonesia, Jakarta, Indonesia Univ Indonesia Jakarta IndonesiaUniv Indonesia, Jakarta, Indonesia Padjadjaran Univ, Bandung, Indonesia Padjadjaran Univ Bandung IndonesiaPadjadjaran Univ, Bandung, Indonesia BKKBN, Jakarta, Indonesia BKKBN Jakarta IndonesiaBKKBN, Jakarta, Indonesia Univ Andalas, Pandang, Indonesia Univ Andalas Pandang IndonesiaUniv Andalas, Pandang, Indonesia Univ Diponegoro, Semarang, Indonesia Univ Diponegoro Semarang IndonesiaUniv Diponegoro, Semarang, Indonesia Hasanuddin Univ, Ujung Pandang, Indonesia Hasanuddin Univ Ujung Pandang Indonesia Univ, Ujung Pandang, Indonesia Family Planning Assoc Sri Lanka, Colombo, Sri Lanka Family Planning Assoc Sri Lanka Colombo Sri Lanka a, Colombo, Sri Lanka Siriraj Hosp, Bangkok, Thailand Siriraj Hosp Bangkok ThailandSiriraj Hosp, Bangkok, Thailand Rajvithi Hosp, Bangkok, Thailand Rajvithi Hosp Bangkok ThailandRajvithi Hosp, Bangkok, Thailand Suan Dok Hosp, Chiang Mai, Thailand Suan Dok Hosp Chiang Mai ThailandSuan Dok Hosp, Chiang Mai, Thailand Mother & Child Hosp, Khon Kaen, Thailand Mother & Child Hosp Khon Kaen Thailand Child Hosp, Khon Kaen, Thailand UNDP UNFPA WHO World Bank Special Programme, Res Dev & Res Training Human Reprod, Geneva, Switzerland UNDP UNFPA WHO World Bank Special Programme Geneva Switzerland tzerland Family Hlth Int, Res Triangle Pk, NC 27709 USA Family Hlth Int Res Triangle Pk NC USA 27709 es Triangle Pk, NC 27709 USA McMaster Univ, Hamilton, ON L8S 4L8, Canada McMaster Univ Hamilton ON Canada L8S 4L8 iv, Hamilton, ON L8S 4L8, Canada
Titolo Testata:
CONTRACEPTION
fascicolo: 4, volume: 63, anno: 2001,
pagine: 187 - 209
SICI:
0010-7824(200104)63:4<187:PSON(C>2.0.ZU;2-A
Fonte:
ISI
Lingua:
ENG
Soggetto:
CARDIOVASCULAR-DISEASE; ORAL CONTRACEPTION; 3-YEAR EXPERIENCE; MAJOR DEPRESSION; RISK; INDIVIDUALS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
34
Recensione:
Indirizzi per estratti:
Indirizzo: Farley, TMM WHO, CH-1211 Geneva, Switzerland WHO Geneva Switzerland CH-1211 , CH-1211 Geneva, Switzerland
Citazione:
T.M.M. Farley e I. Sivin, "Post-marketing surveillance of Norplant (R) contraceptive implants: II. Non-reproductive health", CONTRACEPT, 63(4), 2001, pp. 187-209

Abstract

This controlled cohort study aimed to evaluate the safety and efficacy of Norplant contraceptive implants in developing countries. Women initiating Norplant implants were index subjects and women initiating intrauterine devices (IUDs) or surgical sterilization were controls. Consenting participantsat 32 clinics in eight developing countries were admitted and followed-up every 6 months for 5 years. Major and less serious health events during follow-up were recorded. Incidence rate ratios of health events adjusted for clinic were estimated for initial and current method use. This paper reportsnon-reproductive health events. The study involved 7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of sterilization. Five years follow-up was completed for 94.6% of the women. The study accumulated 78,323 woman-years of observation. The initial method chosen accounted for 84.4% or more of observed woman-years in users of Norplant, IUD, or sterilization. Twenty-two of the recorded 34 deaths were due to accidents, suicide or homicide. Few deaths or major health events were due to cancer or acute cardiovascular diseases and were not associated with the contraceptive method used. The incidence rates of major health events were low and with two exceptions, there was no significant excess risk of serious morbidity for Norplant users compared with controls: among Norplant initiators gallbladder disease occurred at an incidence rate of 1.5 per 1,000 woman-years and was weakly associated with use of Norplant (rate ratio 1.52 [95% C.I. 1.02, 2.27]). For current Norplant users compared to controls, the rate ratio of a combined variable of hypertension and borderline hypertension was significantly elevated (1.81, [1.12, 2.92]). The occurrence of less serious health events was also low and several of them were significantly more often reported among Norplant users. Headache-migraine, weight gain, mood disturbances, pruritus,eczema, and acne had incidence rates among Norplant users of 11.5, 4.5, 2.8, 1.5, 1.4, and 0.9 per 1,000 woman-years, respectively, and were significantly higher than in controls. Respiratory health problems, nonspecific symptoms, and several ill-defined conditions were also significantly more often reported for Norplant users, but some of the excess incidence may be attributable to reporting and detection bias. The study confirms the safety with respect to serious disease of Norplant, IUDs, and sterilization. (C) 2001Elsevier Science Inc. All rights reserved.

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Documento generato il 01/12/20 alle ore 12:56:00