Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial
Purpose This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD). Methods We conducted a prospective, randomized, double-blinded, placebo-cont...
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Veröffentlicht in: | Archives of gynecology and obstetrics 2020-06, Vol.301 (6), p.1463-1471 |
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creator | Samy, Ahmed Abdelhakim, Ahmed Mohamed Latif, Dina Hamza, Mohamed Osman, Omneya M. Metwally, Ahmed A. |
description | Purpose
This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).
Methods
We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.
Results
Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3;
p
|
doi_str_mv | 10.1007/s00404-020-05543-0 |
format | Article |
fullrecord | <record><control><sourceid>proquest_webof</sourceid><recordid>TN_cdi_proquest_miscellaneous_2393039951</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2393039951</sourcerecordid><originalsourceid>FETCH-LOGICAL-c375t-d5e20ff47642f83f54709d00d6bdc8962e64c6c741cd3a708ad06518ee88d4ef3</originalsourceid><addsrcrecordid>eNqNkc2KFDEUhQtRnHH0BVxIwI0gpTeVpH7caeMfDLjRdZFKbjUZUsmYpHpon9JH8nb3OIILMRCS3HznkpxTVU85vOIA3esMIEHW0EANSklRw73qnEvR1NBxfr86h-Gwh7Y7qx7lfAXAm75vH1ZnohFcAlfn1c93GHB2JbM4s53euqA9sy7E6xRziQGZtosLLpeki4uBXScXEyuRedzFENMW6Qp9TRN1dmHLXCB2LZgcqfM-F1yoljEd9S6wm7hgYBa922FCy2LwezbtGXUwhWrMYNYJdWD5UIjhDdMs6WDj4n4Qb-M6eawn74Klo6HVGXp2SU77x9WDWfuMT27Xi-rbh_dfN5_qyy8fP2_eXtZGdKrUVmED8yy7VjZzL2YlOxgsgG0na_qhbbCVpjWd5MYK3UGvLbSK94h9byXO4qJ6cepLRn1fyYRxcdmg9zpgXPPYiEGAGAbFCX3-F3oV10RGEyWhbZTgCohqTpQh53PCeSSrF532I4fxkPd4ynukvMdj3uNB9Oy29TotaO8kvwMmoD8BNzjFORuHweAdBgCq6aSi9jT4xpVjyJu4hkLSl_8vJVqc6ExE2GL688l_vP8XctLcrA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2406253150</pqid></control><display><type>article</type><title>Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial</title><source>MEDLINE</source><source>SpringerLink</source><source>Web of Science - Science Citation Index Expanded - 2020<img src="https://exlibris-pub.s3.amazonaws.com/fromwos-v2.jpg" /></source><creator>Samy, Ahmed ; Abdelhakim, Ahmed Mohamed ; Latif, Dina ; Hamza, Mohamed ; Osman, Omneya M. ; Metwally, Ahmed A.</creator><creatorcontrib>Samy, Ahmed ; Abdelhakim, Ahmed Mohamed ; Latif, Dina ; Hamza, Mohamed ; Osman, Omneya M. ; Metwally, Ahmed A.</creatorcontrib><description>Purpose
This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).
Methods
We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.
Results
Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3;
p
< 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6;
p
= 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8;
p
< 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1;
p
< 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8;
p
< 0.001), respectively. Adverse events were not significantly different between both groups.
Conclusion
Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.</description><identifier>ISSN: 0932-0067</identifier><identifier>EISSN: 1432-0711</identifier><identifier>DOI: 10.1007/s00404-020-05543-0</identifier><identifier>PMID: 32314015</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Abdomen ; Adult ; Birth control ; Cervix ; Cesarean section ; Cesarean Section - methods ; Clinical trials ; Contraceptive Agents, Hormonal - pharmacology ; Contraceptive Agents, Hormonal - therapeutic use ; Dinoprostone - pharmacology ; Dinoprostone - therapeutic use ; Double-Blind Method ; Endocrinology ; Family planning ; Female ; General Gynecology ; Gynecology ; Human Genetics ; Humans ; Intrauterine devices ; Intrauterine Devices, Medicated - standards ; IUD ; Levonorgestrel - pharmacology ; Levonorgestrel - therapeutic use ; Life Sciences & Biomedicine ; Medicine ; Medicine & Public Health ; Menstruation ; Obstetrics ; Obstetrics & Gynecology ; Obstetrics/Perinatology/Midwifery ; Oxytocics - pharmacology ; Oxytocics - therapeutic use ; Pain ; Patient satisfaction ; Pregnancy ; Prospective Studies ; Science & Technology ; Uterus ; Vagina</subject><ispartof>Archives of gynecology and obstetrics, 2020-06, Vol.301 (6), p.1463-1471</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020</rights><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2020.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>true</woscitedreferencessubscribed><woscitedreferencescount>1</woscitedreferencescount><woscitedreferencesoriginalsourcerecordid>wos000527451000001</woscitedreferencesoriginalsourcerecordid><citedby>FETCH-LOGICAL-c375t-d5e20ff47642f83f54709d00d6bdc8962e64c6c741cd3a708ad06518ee88d4ef3</citedby><cites>FETCH-LOGICAL-c375t-d5e20ff47642f83f54709d00d6bdc8962e64c6c741cd3a708ad06518ee88d4ef3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00404-020-05543-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00404-020-05543-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,781,785,27929,27930,28253,41493,42562,51324</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32314015$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Samy, Ahmed</creatorcontrib><creatorcontrib>Abdelhakim, Ahmed Mohamed</creatorcontrib><creatorcontrib>Latif, Dina</creatorcontrib><creatorcontrib>Hamza, Mohamed</creatorcontrib><creatorcontrib>Osman, Omneya M.</creatorcontrib><creatorcontrib>Metwally, Ahmed A.</creatorcontrib><title>Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial</title><title>Archives of gynecology and obstetrics</title><addtitle>Arch Gynecol Obstet</addtitle><addtitle>ARCH GYNECOL OBSTET</addtitle><addtitle>Arch Gynecol Obstet</addtitle><description>Purpose
This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).
Methods
We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.
Results
Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3;
p
< 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6;
p
= 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8;
p
< 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1;
p
< 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8;
p
< 0.001), respectively. Adverse events were not significantly different between both groups.
Conclusion
Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.</description><subject>Abdomen</subject><subject>Adult</subject><subject>Birth control</subject><subject>Cervix</subject><subject>Cesarean section</subject><subject>Cesarean Section - methods</subject><subject>Clinical trials</subject><subject>Contraceptive Agents, Hormonal - pharmacology</subject><subject>Contraceptive Agents, Hormonal - therapeutic use</subject><subject>Dinoprostone - pharmacology</subject><subject>Dinoprostone - therapeutic use</subject><subject>Double-Blind Method</subject><subject>Endocrinology</subject><subject>Family planning</subject><subject>Female</subject><subject>General Gynecology</subject><subject>Gynecology</subject><subject>Human Genetics</subject><subject>Humans</subject><subject>Intrauterine devices</subject><subject>Intrauterine Devices, Medicated - standards</subject><subject>IUD</subject><subject>Levonorgestrel - pharmacology</subject><subject>Levonorgestrel - therapeutic use</subject><subject>Life Sciences & Biomedicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Menstruation</subject><subject>Obstetrics</subject><subject>Obstetrics & Gynecology</subject><subject>Obstetrics/Perinatology/Midwifery</subject><subject>Oxytocics - pharmacology</subject><subject>Oxytocics - therapeutic use</subject><subject>Pain</subject><subject>Patient satisfaction</subject><subject>Pregnancy</subject><subject>Prospective Studies</subject><subject>Science & Technology</subject><subject>Uterus</subject><subject>Vagina</subject><issn>0932-0067</issn><issn>1432-0711</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>AOWDO</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqNkc2KFDEUhQtRnHH0BVxIwI0gpTeVpH7caeMfDLjRdZFKbjUZUsmYpHpon9JH8nb3OIILMRCS3HznkpxTVU85vOIA3esMIEHW0EANSklRw73qnEvR1NBxfr86h-Gwh7Y7qx7lfAXAm75vH1ZnohFcAlfn1c93GHB2JbM4s53euqA9sy7E6xRziQGZtosLLpeki4uBXScXEyuRedzFENMW6Qp9TRN1dmHLXCB2LZgcqfM-F1yoljEd9S6wm7hgYBa922FCy2LwezbtGXUwhWrMYNYJdWD5UIjhDdMs6WDj4n4Qb-M6eawn74Klo6HVGXp2SU77x9WDWfuMT27Xi-rbh_dfN5_qyy8fP2_eXtZGdKrUVmED8yy7VjZzL2YlOxgsgG0na_qhbbCVpjWd5MYK3UGvLbSK94h9byXO4qJ6cepLRn1fyYRxcdmg9zpgXPPYiEGAGAbFCX3-F3oV10RGEyWhbZTgCohqTpQh53PCeSSrF532I4fxkPd4ynukvMdj3uNB9Oy29TotaO8kvwMmoD8BNzjFORuHweAdBgCq6aSi9jT4xpVjyJu4hkLSl_8vJVqc6ExE2GL688l_vP8XctLcrA</recordid><startdate>20200601</startdate><enddate>20200601</enddate><creator>Samy, Ahmed</creator><creator>Abdelhakim, Ahmed Mohamed</creator><creator>Latif, Dina</creator><creator>Hamza, Mohamed</creator><creator>Osman, Omneya M.</creator><creator>Metwally, Ahmed A.</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature</general><general>Springer Nature B.V</general><scope>AOWDO</scope><scope>BLEPL</scope><scope>DTL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20200601</creationdate><title>Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial</title><author>Samy, Ahmed ; Abdelhakim, Ahmed Mohamed ; Latif, Dina ; Hamza, Mohamed ; Osman, Omneya M. ; Metwally, Ahmed A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c375t-d5e20ff47642f83f54709d00d6bdc8962e64c6c741cd3a708ad06518ee88d4ef3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Abdomen</topic><topic>Adult</topic><topic>Birth control</topic><topic>Cervix</topic><topic>Cesarean section</topic><topic>Cesarean Section - methods</topic><topic>Clinical trials</topic><topic>Contraceptive Agents, Hormonal - pharmacology</topic><topic>Contraceptive Agents, Hormonal - therapeutic use</topic><topic>Dinoprostone - pharmacology</topic><topic>Dinoprostone - therapeutic use</topic><topic>Double-Blind Method</topic><topic>Endocrinology</topic><topic>Family planning</topic><topic>Female</topic><topic>General Gynecology</topic><topic>Gynecology</topic><topic>Human Genetics</topic><topic>Humans</topic><topic>Intrauterine devices</topic><topic>Intrauterine Devices, Medicated - standards</topic><topic>IUD</topic><topic>Levonorgestrel - pharmacology</topic><topic>Levonorgestrel - therapeutic use</topic><topic>Life Sciences & Biomedicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Menstruation</topic><topic>Obstetrics</topic><topic>Obstetrics & Gynecology</topic><topic>Obstetrics/Perinatology/Midwifery</topic><topic>Oxytocics - pharmacology</topic><topic>Oxytocics - therapeutic use</topic><topic>Pain</topic><topic>Patient satisfaction</topic><topic>Pregnancy</topic><topic>Prospective Studies</topic><topic>Science & Technology</topic><topic>Uterus</topic><topic>Vagina</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Samy, Ahmed</creatorcontrib><creatorcontrib>Abdelhakim, Ahmed Mohamed</creatorcontrib><creatorcontrib>Latif, Dina</creatorcontrib><creatorcontrib>Hamza, Mohamed</creatorcontrib><creatorcontrib>Osman, Omneya M.</creatorcontrib><creatorcontrib>Metwally, Ahmed A.</creatorcontrib><collection>Web of Science - Science Citation Index Expanded - 2020</collection><collection>Web of Science Core Collection</collection><collection>Science Citation Index Expanded</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Complete (ProQuest)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Archives of gynecology and obstetrics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Samy, Ahmed</au><au>Abdelhakim, Ahmed Mohamed</au><au>Latif, Dina</au><au>Hamza, Mohamed</au><au>Osman, Omneya M.</au><au>Metwally, Ahmed A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial</atitle><jtitle>Archives of gynecology and obstetrics</jtitle><stitle>Arch Gynecol Obstet</stitle><stitle>ARCH GYNECOL OBSTET</stitle><addtitle>Arch Gynecol Obstet</addtitle><date>2020-06-01</date><risdate>2020</risdate><volume>301</volume><issue>6</issue><spage>1463</spage><epage>1471</epage><pages>1463-1471</pages><issn>0932-0067</issn><eissn>1432-0711</eissn><abstract>Purpose
This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD).
Methods
We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged ≥ 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects.
Results
Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 ± 1.7 vs 6.4 ± 1.3;
p
< 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 ± 1.1 vs 3.7 ± 1.6;
p
= 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 ± 1.0 vs 5.9 ± 0.8;
p
< 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 ± 1.1 vs 5.9 ± 1.1;
p
< 0.001) and (5.6 ± 0.9 vs 7.2 ± 0.8;
p
< 0.001), respectively. Adverse events were not significantly different between both groups.
Conclusion
Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>32314015</pmid><doi>10.1007/s00404-020-05543-0</doi><tpages>9</tpages></addata></record> |
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subjects | Abdomen Adult Birth control Cervix Cesarean section Cesarean Section - methods Clinical trials Contraceptive Agents, Hormonal - pharmacology Contraceptive Agents, Hormonal - therapeutic use Dinoprostone - pharmacology Dinoprostone - therapeutic use Double-Blind Method Endocrinology Family planning Female General Gynecology Gynecology Human Genetics Humans Intrauterine devices Intrauterine Devices, Medicated - standards IUD Levonorgestrel - pharmacology Levonorgestrel - therapeutic use Life Sciences & Biomedicine Medicine Medicine & Public Health Menstruation Obstetrics Obstetrics & Gynecology Obstetrics/Perinatology/Midwifery Oxytocics - pharmacology Oxytocics - therapeutic use Pain Patient satisfaction Pregnancy Prospective Studies Science & Technology Uterus Vagina |
title | Benefits of vaginal dinoprostone administration prior to levonorgestrel-releasing intrauterine system insertion in women delivered only by elective cesarean section: a randomized double-blinded clinical trial |
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