Immediate postpartum versus 6-week postpartum intrauterine device insertion: a feasibility study of a randomized controlled trial

Amy G. Bryant, Gift Kamanga, Gretchen S. Stuart, Lisa B. Haddad, Tarek Meguid, Chisale Mhango

Abstract

This study aimed to evaluate the feasibility of conducting a randomized controlled trial of postpartum intrauterine device insertion and to demonstrate that the postpartum intrauterine device is acceptable to women. Women attending prenatal care at a maternity hospital in Lilongwe, Malawi were recruited into a trial comparing immediate (10 minutes to 48 hours) to 6 week postpartum insertion.  Feasibility of recruiting and consenting 140 women and randomizing 70% of them was evaluated.  Satisfaction with the intrauterine device was also assessed. One hundred fifteen women consented and 49 (61%) were randomized.   Twenty-six women were assigned to immediate insertion, and 23 to insertion at 6 weeks postpartum.  Thirty (24%) women received the device as part of the study protocol, and 28(93%) had the device in place at 12 weeks postpartum. The intrauterine device is acceptable to some postpartum women in Malawi, but conducting a randomized clinical trial may not be feasible.  (ClinicalTrials.gov NCT01175161)  (Afr J Reprod Health 2013; 17[2]: 72-79).

Résumé

Cette étude comme objectif d’évaluer la faisabilité d'un essai contrôlé randomisé de l’insertion d’un dispositif intra-utérin du postpartum et de démontrer que le dispositif intra-utérin du postpartum est acceptable pour les femmes. Les femmes qui reçoivent des soins prénatals dans un hôpital de maternité à Lilongwe, au Malawi ont été recrutées dans un essai comparant immédiat (10 minutes à 48 heures) à  l’insertion des six semaines du post-partum.  La  faisabilité du recrutement et du consentement et de la randomisation de 140 femmes dont 70% ont été évaluées. La satisfaction à l'égard du dispositif intra-utérin a également été évaluée. Cent quinze femmes ont consenti et 49 (61%) ont été randomisées. Vingt-six femmes ont été affectées à l'insertion immédiate, et 23 à l'insertion à 6 semaines après l'accouchement. Trente (24%) des femmes ont reçu du dispositif dans le cadre du protocole de l'étude, et 28 (93%) avaient le dispositif en place à 12 semaines après l'accouchement. Le dispositif intra-utérin est acceptable aux  certaines femmes en post-partum au Malawi, mais  un essai clinique randomisé peut ne pas être possible d’effectuer. (Afr J Reprod Health 2013; 17[2]: 72-79).

 

 Keywords: postpartum intrauterine device, IUD, Africa, randomized controlled trial, long-acting reversible contraception

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References

Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010;116(5):1079-87.

Hayes JL, Cwiak C, Goedken P, Zieman M. A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device. Contraception. 2007;76(4):292-6.

Stuart G, Bryant, AG, O'Neill, E, Doherty, I. Feasibility of postpartum placement of the levonorgestrel intrauterine system more than six hours after vaginal birth Contraception. 2011;In press.

Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel-intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011;84(3):244-8. Epub 2011/08/17.

Blumenthal PD, Voedisch A, Gemzell-Danielsson K. Strategies to prevent unintended pregnancy: increasing use of long-acting reversible contraception. Hum Reprod Update. 2011;17(1):121-37.

Kapp N, Curtis KM. Intrauterine device insertion during the postpartum period: a systematic review. Contraception. 2009;80(4):327-36.

Morrison C, Waszak C, Katz K, Diabate F, Mate EM. Clinical outcomes of two early postpartum IUD insertion programs in Africa. Contraception. 1996;53(1):17-21.

Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, et al. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year followup. Contraception. 2006;74(5):376-81.

O'Hanley K, Huber DH. Postpartum IUDS: keys for success. Contraception. 1992;45(4):351-61.

Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gynecol.

;115(5):1063-70.

Williamson LM, Parkes A, Wight D, Petticrew M, Hart GJ. Limits to modern contraceptive use among young women in developing countries: a systematic review of qualitative research. Reprod Health. 2009;6:3.

http://www.unicef.org/infobycountry/malawi_statistics.ht

ml. [February 23, 2011]; Available from: http://www.unicef.org/infobycountry/malawi_statistic s.html.

Chipeta EK, Chimwaza W, Kalilani-Phiri L.

Contraceptive knowledge, beliefs and attitudes in rural Malawi: misinformation, misbeliefs and misperceptions. Malawi Med J. 2010;22(2):38-41.

Bankole AS, Susheela. Couples' Fertility and Contraceptive Decision-Making In Developing Countries: Hearing the Man's Voice. International Family Planning Perspectives. 1998;24(1):15-24.

Mbizvo MT, Bassett MT. Reproductive health and AIDS prevention in sub-Saharan Africa: the case for increased male participation. Health Policy Plan. 1996;11(1):84-92.

Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane database of systematic reviews (Online). 2010(5):CD003036.

Dickersin K. How important is publication bias? A synthesis of available data. AIDS Educ Prev. 1997;9(1 Suppl):15-21.

Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS One. 2008;3(8):e3081.

Blumenthal PD, Shiliya N, Neukom, J, Chilambwe, J,

Vwalika, B, Prager, S, Gupta, P, Espey, E, Eber, M Expulsion rates and satisfaction levels among postpartum IUD users in peri-urban Lusaka, Zambia. North American Forum on Family Planning; Washington, DC: Contraception; 2011. p. (84)320.

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