Misoprostol as a family planning drug : use in pregnant and non-pregnant women
Author: Sääv, Ingrid
Date: 2014-11-21
Location: Skandiasalen, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital, Solna
Time: 09.00
Department: Inst för kvinnors och barns hälsa / Dept of Women's and Children's Health
Abstract
Background: Availability of comprehensive family planning services is fundamental in improving and ensuring women’s right to life and health. An estimated 222 million women have an unmet need for contraception, and 43.8 million pregnancies are terminated each year, of which 21.6 million are considered to be unsafe and one of the main contributors to maternal mortality and morbidity. Medical abortion using misoprostol alone, or preferably the combined regimen of mifepristone and misoprostol, is the medical development that could turn out to be the most important in the goal of reducing maternal mortality worldwide. Modern equipment and training cannot be provided where abortion is illegal. Thus, a medical method, administered by women themselves is a promising way to modernise and make abortion safe and accessible. Medical priming prior to vacuum aspiration has been proven to reduce the rate of complications, and should be standard care. Information on dosage and priming interval is crucial for safety and effectiveness.
The effectiveness of long-acting reversible contraception (LARC) such as intrauterine contraception (IUC) is superior to short-acting contraception, the difference being most pronounced in young women. Furthermore, women, who have an IUC inserted post abortion, are less likely to have a repeat unwanted pregnancy and abortion. Therefore efforts are needed to facilitate IUC use in these groups. Methods and Results:
Study I: Nulliparous women requesting a Cu-IUD were recruited (n=80), and randomised to priming with misoprostol and diclofenac, or to only diclofenac one hour prior to IUC insertion. Misoprostol was shown to facilitate insertion of IUC in nulliparous women, and to decrease the rate of difficult and failed insertions. Priming with misoprostol did not reduce pain associated with the IUC placement.
Study II: Lactating mothers undergoing medical abortion were recruited and samples of breast-milk collected during the first seven days after mifepristone treatment (n=12). Levels of mifepristone in breast-milk were low, with milk-plasma levels of 0.042:1 or less and calculated RID of 0.5 %.
Study III: Healthy women requesting medical first trimester abortion and IUC post abortion were recruited (n=129), and randomized to early insertion during the first week, or to routine, delayed insertion. There was no increased rate of expulsions, PID or bleeding complications after early IUC insertion.
Study IV: Healthy women undergoing vacuum aspiration were recruited (n=184), and randomised to priming with misoprostol sublingual (SL) or vaginal (PV), one or three hours before surgery. SL misoprostol was proven to be as effective after one hour as after three hours priming interval in regard to baseline cervical dilatation, peak force and cumulative force. SL misoprostol was more effective compared with PV misoprostol after one hour priming. Fewer women started bleeding prior to surgical intervention when priming interval was one hour.
Conclusion: SL misoprostol reduces the cervical resistance after one hour priming interval, and can be used to facilitate insertion of an IUC to reduce difficult or failed insertions. Priming with SL misoprostol prior to vacuum aspiration is as effective after one hour as after three hours, and fewer women start bleeding before surgery. If PV misoprostol is used, the priming interval should remain at three hours. Medical abortion can be the method of choice for nursing mothers, and breastfeeding can be safely continued in an uninterrupted manner. After first trimester medical abortion, early IUC insertion is safe with no increased risk of expulsion or complications, and should therefore be offered as a routine, to ensure rapid initiation of highly effective contraception.
The effectiveness of long-acting reversible contraception (LARC) such as intrauterine contraception (IUC) is superior to short-acting contraception, the difference being most pronounced in young women. Furthermore, women, who have an IUC inserted post abortion, are less likely to have a repeat unwanted pregnancy and abortion. Therefore efforts are needed to facilitate IUC use in these groups. Methods and Results:
Study I: Nulliparous women requesting a Cu-IUD were recruited (n=80), and randomised to priming with misoprostol and diclofenac, or to only diclofenac one hour prior to IUC insertion. Misoprostol was shown to facilitate insertion of IUC in nulliparous women, and to decrease the rate of difficult and failed insertions. Priming with misoprostol did not reduce pain associated with the IUC placement.
Study II: Lactating mothers undergoing medical abortion were recruited and samples of breast-milk collected during the first seven days after mifepristone treatment (n=12). Levels of mifepristone in breast-milk were low, with milk-plasma levels of 0.042:1 or less and calculated RID of 0.5 %.
Study III: Healthy women requesting medical first trimester abortion and IUC post abortion were recruited (n=129), and randomized to early insertion during the first week, or to routine, delayed insertion. There was no increased rate of expulsions, PID or bleeding complications after early IUC insertion.
Study IV: Healthy women undergoing vacuum aspiration were recruited (n=184), and randomised to priming with misoprostol sublingual (SL) or vaginal (PV), one or three hours before surgery. SL misoprostol was proven to be as effective after one hour as after three hours priming interval in regard to baseline cervical dilatation, peak force and cumulative force. SL misoprostol was more effective compared with PV misoprostol after one hour priming. Fewer women started bleeding prior to surgical intervention when priming interval was one hour.
Conclusion: SL misoprostol reduces the cervical resistance after one hour priming interval, and can be used to facilitate insertion of an IUC to reduce difficult or failed insertions. Priming with SL misoprostol prior to vacuum aspiration is as effective after one hour as after three hours, and fewer women start bleeding before surgery. If PV misoprostol is used, the priming interval should remain at three hours. Medical abortion can be the method of choice for nursing mothers, and breastfeeding can be safely continued in an uninterrupted manner. After first trimester medical abortion, early IUC insertion is safe with no increased risk of expulsion or complications, and should therefore be offered as a routine, to ensure rapid initiation of highly effective contraception.
List of papers:
I. Ingrid Sääv, Annette Aronsson, Lena Marions, Olof Stephansson and Kristina Gemzell-Danielsson. Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial. Human Reproduction. 2007;22: 2647–2652.
Fulltext (DOI)
Pubmed
View record in Web of Science®
II. Ingrid Sääv, Christian Fiala, Jonna M Hämäläinen, Oskari Heikinheimo and Kristina Gemzell-Danielsson. Medical abortion in lactating women – low levels of mifepristone in breast milk. Acta Obstetricia et Gynecologica. 2010; 89: 618–622.
Fulltext (DOI)
Pubmed
View record in Web of Science®
III. Ingrid Sääv, Olof Stephansson, and Kristina Gemzell-Danielsson. Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial. PLoS ONE. 7(11): e48948.
Fulltext (DOI)
Pubmed
View record in Web of Science®
IV. Ingrid Sääv, Helena Kopp Kallner, Christian Fiala, Kristina Gemzell-Danielsson. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 hours prior to surgical abortion. A randomised, controlled, double-blinded trial. [Manuscript]
I. Ingrid Sääv, Annette Aronsson, Lena Marions, Olof Stephansson and Kristina Gemzell-Danielsson. Cervical priming with sublingual misoprostol prior to insertion of an intrauterine device in nulliparous women: a randomized controlled trial. Human Reproduction. 2007;22: 2647–2652.
Fulltext (DOI)
Pubmed
View record in Web of Science®
II. Ingrid Sääv, Christian Fiala, Jonna M Hämäläinen, Oskari Heikinheimo and Kristina Gemzell-Danielsson. Medical abortion in lactating women – low levels of mifepristone in breast milk. Acta Obstetricia et Gynecologica. 2010; 89: 618–622.
Fulltext (DOI)
Pubmed
View record in Web of Science®
III. Ingrid Sääv, Olof Stephansson, and Kristina Gemzell-Danielsson. Early versus delayed insertion of intrauterine contraception after medical abortion - a randomized controlled trial. PLoS ONE. 7(11): e48948.
Fulltext (DOI)
Pubmed
View record in Web of Science®
IV. Ingrid Sääv, Helena Kopp Kallner, Christian Fiala, Kristina Gemzell-Danielsson. Sublingual versus vaginal misoprostol for cervical dilatation 1 or 3 hours prior to surgical abortion. A randomised, controlled, double-blinded trial. [Manuscript]
Institution: Karolinska Institutet
Supervisor: Gemzell Danielsson, Kristina
Issue date: 2014-10-28
Rights:
Publication year: 2014
ISBN: 978-91-7549-701-3
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