The effect of deliberate non-adherence to a norgestrel progestin-only pill: A randomized, crossover study.


Journal

Contraception
ISSN: 1879-0518
Titre abrégé: Contraception
Pays: United States
ID NLM: 0234361

Informations de publication

Date de publication:
01 2023
Historique:
received: 13 07 2022
revised: 10 09 2022
accepted: 12 09 2022
pubmed: 22 9 2022
medline: 7 12 2022
entrez: 21 9 2022
Statut: ppublish

Résumé

To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill. In a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.0 kg/m² and regular ovulatory cycles completed a baseline 28-day cycle with correct daily pill use followed by two intervention cycles in which, around mid-cycle, one pill was taken 6 hours late or missed completely. We undertook ovarian ultrasonography, estradiol and progesterone measurement, and cervical mucus assessments every 3 to 4 days (daily around the time of the incorrect use) and based the theoretical contraceptive protection score on ovarian activity status, cervical mucus and their temporal relationship. Of 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility. Delayed or missed intake of a single norgestrel 0.075 mg progestogen-only pill appears to have little effect on theoretical contraceptive efficacy. This biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.

Identifiants

pubmed: 36130667
pii: S0010-7824(22)00249-9
doi: 10.1016/j.contraception.2022.09.002
pii:
doi:

Substances chimiques

Norgestrel 3J8Q1747Z2
Progestins 0
Progesterone 4G7DS2Q64Y
Estradiol 4TI98Z838E
Contraceptive Agents 0

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1-6

Subventions

Organisme : Medical Research Council
ID : MR/N022556/1
Pays : United Kingdom

Informations de copyright

Copyright © 2022. Published by Elsevier Inc.

Auteurs

Anna Glasier (A)

College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, UK. Electronic address: Anna.Glasier@ed.ac.uk.

Alison Edelman (A)

Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR, United States.

Mitchell D Creinin (MD)

Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.

Vivian Brache (V)

PROFAMILIA, Santo Domingo, Dominican Republic.

Carolyn L Westhoff (CL)

Department of Obstetrics and Gynecology, Columbia University, New York, NY, United States.

Leo Han (L)

Department of Obstetrics & Gynecology, Oregon Health & Science University, Portland, OR, United States.

Melissa J Chen (MJ)

Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, United States.

Agnes Hemon (A)

Laboratoire HRA Pharma, Chatillon, France.

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Classifications MeSH