Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing

Noa'a Shimoni; Tasmiah Choudhury; Alice R. Goldman; Michelle Frondelli; Ping Hsin Chen

doi:https://doi.org/10.1016/j.contraception.2019.02.004

Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing

Noa'a Shimoni, Tasmiah Choudhury, Alice R. Goldman, Michelle Frondelli, Ping Hsin Chen

New Jersey Medical School (NJMS), Family Medicine

Rutgers, The State University

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

Objective: To assess the impact of early versus late menstrual cycle insertion on bleeding/spotting in the 90 days following levonorgestrel (LNG) 13.5 mg intrauterine system (IUS) insertion. Study design: In this observational study, participants received a LNG 13.5 mg IUS and provided 90 days of bleeding/spotting data by answering the following daily text: “Have you had no flow (0), spotting (1), or bleeding (2) today?” We dichotomized insertion timing as early (days 1–7 from last menstrual period) and late (remainder of menstrual cycle) and compared bleeding/spotting between the two groups in the 90- and 30-day reference periods. We used multivariate regression methods to study associations between cycle day at insertion, parity, historical bleeding, recent hormonal contraceptive use and bleeding/spotting. Results: In the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding or spotting between the early and late insertion groups. In the 30-day dichotomous analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion (5±3 vs. 7±4 days, p<.01). Recent hormonal contraceptive users experienced fewer days of bleeding than new users (5±4 vs. 7±3 days, p<.01). In the 90- and 30-day regression models, earlier insertion was associated with fewer days of bleeding (p=.02, p=.02). Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day, p=.03) and fewer days of bleeding (30-day, p<.01). Nulliparity was associated with spotting (30-day, p=.04). Conclusions: Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding. Implications: The LNG 13.5 mg IUS may be inserted throughout the menstrual cycle with small differences in bleeding patterns in the 30 but not the 90 days following insertion. Shared decision making should determine timing of insertion.

Original language	American English
Pages (from-to)	340-344
Number of pages	5
Journal	Contraception
Volume	99
Issue number	6
DOIs	https://doi.org/10.1016/j.contraception.2019.02.004
State	Published - Jun 2019

ASJC Scopus subject areas

Reproductive Medicine
Obstetrics and Gynecology

Keywords

Bleeding
Bleeding pattern
Insertion timing
Intrauterine system
Levonorgestrel intrauterine system
Spotting

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https://doi.org/10.1016/j.contraception.2019.02.004

Cite this

@article{254c55d0ce05458993d5926bcd459872,

title = "Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing",

abstract = "Objective: To assess the impact of early versus late menstrual cycle insertion on bleeding/spotting in the 90 days following levonorgestrel (LNG) 13.5 mg intrauterine system (IUS) insertion. Study design: In this observational study, participants received a LNG 13.5 mg IUS and provided 90 days of bleeding/spotting data by answering the following daily text: “Have you had no flow (0), spotting (1), or bleeding (2) today?” We dichotomized insertion timing as early (days 1–7 from last menstrual period) and late (remainder of menstrual cycle) and compared bleeding/spotting between the two groups in the 90- and 30-day reference periods. We used multivariate regression methods to study associations between cycle day at insertion, parity, historical bleeding, recent hormonal contraceptive use and bleeding/spotting. Results: In the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding or spotting between the early and late insertion groups. In the 30-day dichotomous analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion (5±3 vs. 7±4 days, p<.01). Recent hormonal contraceptive users experienced fewer days of bleeding than new users (5±4 vs. 7±3 days, p<.01). In the 90- and 30-day regression models, earlier insertion was associated with fewer days of bleeding (p=.02, p=.02). Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day, p=.03) and fewer days of bleeding (30-day, p<.01). Nulliparity was associated with spotting (30-day, p=.04). Conclusions: Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding. Implications: The LNG 13.5 mg IUS may be inserted throughout the menstrual cycle with small differences in bleeding patterns in the 30 but not the 90 days following insertion. Shared decision making should determine timing of insertion.",

keywords = "Bleeding, Bleeding pattern, Insertion timing, Intrauterine system, Levonorgestrel intrauterine system, Spotting",

author = "Noa'a Shimoni and Tasmiah Choudhury and Goldman, {Alice R.} and Michelle Frondelli and Chen, {Ping Hsin}",

note = "Funding Information: Funding sources: This work was supported by Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA. Bayer was not involved in study design, data collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication.☆ Funding sources: This work was supported by Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA. Bayer was not involved in study design, data collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication. We thank our participating sites for their support: Rutgers New Jersey Family Practice Center; Planned Parenthood of Northern, Central and Southern New Jersey; and Student Health Services at Rutgers Health Sciences Campus.☆ Funding sources: This work was supported by Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA. Bayer was not involved in study design, data collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication. Publisher Copyright: {\textcopyright} 2019 Elsevier Inc.",

year = "2019",

month = jun,

doi = "https://doi.org/10.1016/j.contraception.2019.02.004",

language = "American English",

volume = "99",

pages = "340--344",

journal = "Contraception",

issn = "0010-7824",

publisher = "Elsevier USA",

number = "6",

}

TY - JOUR

T1 - Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system

T2 - the impact of insertion timing

AU - Shimoni, Noa'a

AU - Choudhury, Tasmiah

AU - Goldman, Alice R.

AU - Frondelli, Michelle

AU - Chen, Ping Hsin

N1 - Funding Information: Funding sources: This work was supported by Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA. Bayer was not involved in study design, data collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication.☆ Funding sources: This work was supported by Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA. Bayer was not involved in study design, data collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication. We thank our participating sites for their support: Rutgers New Jersey Family Practice Center; Planned Parenthood of Northern, Central and Southern New Jersey; and Student Health Services at Rutgers Health Sciences Campus.☆ Funding sources: This work was supported by Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA. Bayer was not involved in study design, data collection, analysis, interpretation of data, writing of the report or the decision to submit the article for publication. Publisher Copyright: © 2019 Elsevier Inc.

PY - 2019/6

Y1 - 2019/6

N2 - Objective: To assess the impact of early versus late menstrual cycle insertion on bleeding/spotting in the 90 days following levonorgestrel (LNG) 13.5 mg intrauterine system (IUS) insertion. Study design: In this observational study, participants received a LNG 13.5 mg IUS and provided 90 days of bleeding/spotting data by answering the following daily text: “Have you had no flow (0), spotting (1), or bleeding (2) today?” We dichotomized insertion timing as early (days 1–7 from last menstrual period) and late (remainder of menstrual cycle) and compared bleeding/spotting between the two groups in the 90- and 30-day reference periods. We used multivariate regression methods to study associations between cycle day at insertion, parity, historical bleeding, recent hormonal contraceptive use and bleeding/spotting. Results: In the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding or spotting between the early and late insertion groups. In the 30-day dichotomous analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion (5±3 vs. 7±4 days, p<.01). Recent hormonal contraceptive users experienced fewer days of bleeding than new users (5±4 vs. 7±3 days, p<.01). In the 90- and 30-day regression models, earlier insertion was associated with fewer days of bleeding (p=.02, p=.02). Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day, p=.03) and fewer days of bleeding (30-day, p<.01). Nulliparity was associated with spotting (30-day, p=.04). Conclusions: Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding. Implications: The LNG 13.5 mg IUS may be inserted throughout the menstrual cycle with small differences in bleeding patterns in the 30 but not the 90 days following insertion. Shared decision making should determine timing of insertion.

AB - Objective: To assess the impact of early versus late menstrual cycle insertion on bleeding/spotting in the 90 days following levonorgestrel (LNG) 13.5 mg intrauterine system (IUS) insertion. Study design: In this observational study, participants received a LNG 13.5 mg IUS and provided 90 days of bleeding/spotting data by answering the following daily text: “Have you had no flow (0), spotting (1), or bleeding (2) today?” We dichotomized insertion timing as early (days 1–7 from last menstrual period) and late (remainder of menstrual cycle) and compared bleeding/spotting between the two groups in the 90- and 30-day reference periods. We used multivariate regression methods to study associations between cycle day at insertion, parity, historical bleeding, recent hormonal contraceptive use and bleeding/spotting. Results: In the 90-day dichotomous analysis (n=125), we found no differences in the number of days of bleeding/spotting, bleeding or spotting between the early and late insertion groups. In the 30-day dichotomous analysis (n=131), early insertion was associated with fewer days of bleeding than late insertion (5±3 vs. 7±4 days, p<.01). Recent hormonal contraceptive users experienced fewer days of bleeding than new users (5±4 vs. 7±3 days, p<.01). In the 90- and 30-day regression models, earlier insertion was associated with fewer days of bleeding (p=.02, p=.02). Recent contraceptive use was associated with fewer days of bleeding/spotting (90-day, p=.03) and fewer days of bleeding (30-day, p<.01). Nulliparity was associated with spotting (30-day, p=.04). Conclusions: Early cycle insertion does not impact 90-day bleeding/spotting. Early cycle insertion and recent hormonal contraceptive use decrease 30-day bleeding. Implications: The LNG 13.5 mg IUS may be inserted throughout the menstrual cycle with small differences in bleeding patterns in the 30 but not the 90 days following insertion. Shared decision making should determine timing of insertion.

KW - Bleeding

KW - Bleeding pattern

KW - Insertion timing

KW - Intrauterine system

KW - Levonorgestrel intrauterine system

KW - Spotting

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DO - https://doi.org/10.1016/j.contraception.2019.02.004

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C2 - 30831104

SN - 0010-7824

VL - 99

SP - 340

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JO - Contraception

JF - Contraception

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ER -

Bleeding and spotting with the levonorgestrel 13.5 mg intrauterine system: the impact of insertion timing

Abstract

ASJC Scopus subject areas

Keywords

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