Follow-up of immediate postpartum intrauterine device insertion: a scoping review protocol

Abstract

Introduction

The intrauterine device (IUD) inserted immediately after delivery is a safe and effective measure for preventing unplanned pregnancies. Despite exhibiting a higher expulsion rate compared with later insertions, it proves cost-effective due to the high rate of continuity of the method. There is still a gap in the literature regarding the optimal strategy for monitoring these patients, whether it should be through clinical examination, ultrasound or both. The aim of this review is to map the available evidence regarding the proper clinical and ultrasound follow-up procedures of IUDs inserted immediately post partum.

Methods and analysis

Using the well-established scoping review methodology outlined by the Joanna Briggs Institute, a five-stage review is outlined: (1) determining the research question, (2) search strategy, (3) inclusion criteria, (4) data extraction and (5) analysis and presentation of the results. The search strategy will be applied to nine databases reflecting empirical and grey literature. A two-step screening process will be used to determine eligibility of articles. To be included in the review, articles must describe how postpartum women (adolescents or adults) who had an IUD inserted immediately after birth (vaginal or caesarean) were followed up. All articles will be independently assessed for eligibility, and data from eligible articles will be extracted and charted using a standardised form. Extracted data will be analysed using narrative and descriptive analyses.

Ethics and dissemination

Ethics approval is not required. The results will be disseminated to the health science community through professional networks, conference presentations and publication in a scientific journal.

Correspondence to Dr Thuany Bento Herculano; [email protected]

STRENGTHS AND LIMITATIONS OF THIS STUDY

• Application of a rigorous, well-established methodological framework will ensure the production of a high-quality review.

• A comprehensive search will be conducted on nine disciplinary and cross-disciplinary databases to ensure that we will maximise our coverage of all possible records that meet review inclusion criteria.

• Inclusion of grey literature further strengthens our review by reducing publication bias and enhancing the comprehensiveness of the findings.

• To facilitate a timely review given the high number of citations, the synthesis will be limited to articles published in English or Portuguese which increases the risk of missing relevant programmes reported in languages other than English or Portuguese.

Introduction

Offering contraception immediately after childbirth is an effective measure to reduce maternal and neonatal mortality. This reduction occurs due to the increase in the interpregnancy interval and, above all, the prevention of unplanned pregnancies (UP).^{1 2} An UP is associated with twice the risk of severe maternal morbidity from eclampsia, placental abruption and postpartum haemorrhage as a consequence of inadequate prenatal care. It is also associated with twice the risk of perinatal morbidity, including preterm birth, intrauterine growth restriction and fetal death.³

In low- and middle-income countries, there is a high rate of UPs (>50%) and low adherence to long-acting reversible contraceptive (LARC) methods, such as the intrauterine device (IUD).⁴ LARCs are known to be more effective in birth control due to their high rate of efficacy and continuity, and for not requiring user intervention.⁵ In Brazil, less than 2% of women use the IUD, despite being available free of charge by the health system.³

Delaying the start of contraception until the postpartum follow-up consultation, usually performed after 6 weeks of delivery, may place many postpartum women at risk of another UP, especially those with greater socio-economic vulnerability (multiparous, unemployed, substance users and adolescents). This can be due to the high rates of absenteeism at this consultation or a return to unprotected sexual activity.^6–8

IUD insertion immediately after childbirth is considered effective and safe as it has a low potential for complications such as perforation, abnormal bleeding or infection.⁹ Motivation for contraception is typically higher immediately after childbirth,¹⁰ and the fact that the woman is already in the healthcare setting eliminates one of the most significant barriers to IUD insertion—access.^{11 12}

In immediate post partum, there are two distinct intervals for IUD insertion: (1) post-placental and (2) early. The first one involves insertion up to 10 min after placental expulsion. The second one represents insertion performed between 10 min and 48 hours after birth. Insertion between 48 hours and 4 weeks is contraindicated due to the increased potential for complications.⁹

The main concern regarding immediate postpartum IUD insertion is the higher expulsion rate compared with interval insertion (>4 weeks). A Cochrane review of randomised clinical trials showed that despite a higher expulsion rate with immediate insertion, there was a higher adoption rate for patients who were inserted post partum and the same continuation rate at 6 months of follow-up.⁶

Similarly, a recent systematic review with meta-analysis, including observational and interventional studies at different intervals in postpartum period and different devices, concludes that expulsion rates vary by timing of placement, type and mode of birth. This information should be shared, and the patient can decide when to have the insertion; however, they should always be offered.¹³ Cost-effectiveness studies indicate that even with a higher expulsion rate immediate insertion can prevent 88 UPs/1000 women in 2 years of follow-up compared with interval insertion.¹⁴

Additional evidence points to a variety of other factors that may interfere with the risk of expulsion, such as the type of delivery, age, parity and the healthcare professional’s experience. It may also be related to the characteristics of the puerperal uterus itself (size, cervical dilation, postpartum uterine contractions), as well as the technical difficulty in reaching the uterine fundus post partum.^{7 11 13 15}

A systematic review that assessed the utilisation, efficacy and safety of immediate postpartum IUD insertion found that the main difficulty noted among studies was the heterogeneity in patient follow-up. Some studies conducted follow-up consultations solely by phone, while others opted for in-person clinical examinations, including an evaluation of the device string length. In some studies, ultrasound was only performed when there was suspicion of expulsion or perforation.⁹

A small study that evaluated 90 IUDs inserted immediately post partum, through ultrasound performed before hospital discharge and after 6 weeks, concluded that ultrasound may be an effective way to predict success in IUD retention. The authors state that merely visualising the IUD string at the postpartum review consultation is not sufficient to reassure women about the proper placement of the IUD as it could be partially in the endocervical canal pending expulsion.¹⁶

A study comparing clinical examinations with transvaginal ultrasound in the follow-up of IUDs inserted outside the immediate postpartum period showed that routine ultrasound surveillance did not show clear benefits compared with pelvic examination for women without complicated insertion or clinical signs/symptoms of malpositioning (such as pain or bleeding).¹⁷

Most expulsions occur within the first 6 weeks post partum (up to 90%). When complete, they can be diagnosed clinically; however, when partial, only a minority can be diagnosed by physical examination.^{18 19}

Currently, an IUD is considered properly positioned when it is entirely located in the uterine cavity, with its distal end above the internal cervical os, and its arms are laterally oriented. Previously, borderline distances between the device and the uterine fundus were used to consider it well-positioned. However, this distance is dynamic after insertion and varies during the menstrual cycle and with puerperal uterine involution. It is unknown whether rotation changes alone, a possible event in postpartum insertions, have clinically relevant significance in the failure of the method, although they may be related to reports of pain and increased bleeding.^19–21

There should be a consistent benefit for routinely recommending ultrasound after postpartum IUD insertion, with an impact on the method’s success rate and prevention of unintended pregnancy. The primary objective of immediate insertion is to address the accessibility challenge faced by these women in accessing effective contraception. Otherwise, we risk creating a new barrier as ultrasound is not widely available in low- and middle-income countries. To address this knowledge gap, regarding how IUD insertion should be monitored in the immediate postpartum period, this scoping review will map the available literature on IUD insertion follow-up in the immediate postpartum period.

Methods and analysis

Published literature on IUD follow-up after birth is likely to appear in a variety of sources and vary in methodological approaches and formats. Using the methods outlined in the Joanna Briggs Institute manual for knowledge synthesis²² and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) guidelines²³ (see online supplemental appendix 1) will allow us to make use of literature across study designs and in both peer-reviewed and grey literature. The study will be completed over five stages: (1) determining the research question, (2) search strategy, (3) inclusion criteria, (4) data extraction and (5) analysis and presentation of the results. Though the study will not entail a quality assessment, scoping reviews are considered a rigorous and systematic approach to knowledge synthesis. Study activities will occur between 2024 and 2025. At this point, we have already completed steps 1–3 and are awaiting approval of this protocol to begin data extraction (step 4). Ethics Review Board approval is not required to conduct this study.

Determining the research question

This review will answer the following research question: How should the follow-up of an IUD inserted immediately post partum be conducted?

Therefore, the main objective of the review will be to determine which type of follow-up is most appropriate for the IUD inserted in the immediate postpartum period: clinical, ultrasound or a combination of both.

The secondary objectives of the scope review are:

• If clinical follow-up with the assessment of the presence and size of the IUD string proves to be effective, determine the postpartum interval for it to be carried out and, subsequently, how frequently the physical examination should be repeated.

• If ultrasound proves to be an effective measure, determine the postpartum interval recommended for its performance and, subsequently, how frequently the ultrasound examination should be repeated.

• Evaluate whether there is a more reliable ultrasound parameter to predict the risk of expulsion in an initially normopositioned device (IUD-endometrium distance; IUD-myometrium distance; uterine width).

• Evaluate whether in IUDs completely inside the uterine cavity, changes in rotation have an impact on their contraceptive effectiveness.

Search strategy

Before initiating this scoping review proposal, a preliminary search was conducted in PROSPERO, MEDLINE (PubMed), the Cochrane Database of Systematic Reviews and the JBI Database of Systematic Reviews and Implementation Reports, and no systematic or pending scoping reviews on the subject were found.

The databases to be searched are MEDLINE (PubMed), PMC (PubMed Central), BVS/Bireme, EBSCOhost, Scopus, Web of Science, EMBASE, Cochrane Library and PROQUEST.

The search for grey literature will include the websites of Gynecology and Obstetrics Federations, the International Society of Ultrasound in Obstetrics and Gynecology, the Networked Digital Library of Theses and Dissertations and internet search engines.

A two-step search strategy will be used for this review. An initial limited search in MEDLINE (PubMed) and PMC (PubMed Central) was performed, followed by an analysis of the words contained in the title and abstract, and index terms used to index the article.

A comprehensive secondary search will be conducted across all included databases using the keywords and index terms identified in the initial limited search. A full search strategy for MEDLINE (PubMed) is included in online supplemental appendix 2. If relevant, the reviewers intend to contact the authors of the primary studies or reviews for further information.

Studies published in English or Portuguese will be included. The review will consider all relevant studies published, with no publication date limits.

Inclusion criteria

The inclusion criteria for this scoping review support the collection and extraction of data relevant to the research question and objectives. Following the JBI construct of population, concept and context, the inclusion criteria are as follows.

Population

The participants in this review will be puerperal women who received the IUD (non-hormonal or hormonal) within the first 48 hours post partum (vaginal or caesarean). This review will consider studies including adolescent or adult women, regardless of parity.

Concept

This review will consider studies that include IUD insertion immediately post partum, that is, within 10 min after placental delivery (post-placental IUD), as well as early insertion, which is done between 10 min and 48 hours post partum. Studies must report, in addition to the timing of insertion and type of delivery, how the follow-up of these patients was conducted, whether with clinical examination, ultrasound or both.

In cases where only clinical examination was performed, the time elapsed since insertion and the strategy used when the device string was not visible will be evaluated. In cases of visible strings, it will be assessed whether the women presented any symptoms indicative of partial expulsion or improper positioning, such as pain or bleeding, and the procedure employed in response to these issues.

In studies where ultrasound follow-up was conducted, the interval and periodicity of its performance will be evaluated, as well as the ultrasound parameters assessed and their correlation with the primary outcome: expulsion (complete or partial). Complete expulsion is defined as total externalisation of the IUD, whether or not perceived by the patient, as the device can be expelled along with postpartum bleeding. Partial expulsion is defined as the IUD being below the internal cervical os, that is, in the endocervical canal.

Another outcome assessed will be uterine perforation (total or partial). Total uterine perforation is defined as the IUD being absent on clinical examination and transvaginal ultrasound but found in the abdominal cavity. Partial perforation involves the IUD being embedded in the myometrium with one of the arms piercing the serosa without having yet fallen into the abdominal cavity.

Additionally, the ultrasound parameters used to define a poorly positioned IUD and the procedures adopted in these cases will be evaluated, as well as whether patients presented clinical issues. Rotation changes will also be recorded: IUDs with transverse arms in the anteroposterior direction or upside down.

Context

This scoping review will only consider studies conducted with women who had hospital births.

Data extraction and analysis

After the search, all identified citations will be collected and uploaded into EndNote (Clarivate Analytics, Pennsylvania, USA), and duplicates will be removed. Titles and abstracts will then be screened by two independent reviewers for eligibility against the review’s inclusion criteria. Potentially relevant studies will be retrieved in full, and their citation details will be imported into the JBI System for the Unified Management, Assessment, and Review of Information (JBI SUMARI; JBI, Adelaide, Australia) and included in the reference list. The full text of selected citations will be critically assessed for eligibility by two independent reviewers. Reasons for the exclusion of full-text studies that do not meet the inclusion criteria will be recorded and reported in the scoping review. Eventual disagreements between reviewers at each stage of the study selection process will be resolved through discussion or by a third reviewer. The search results will be reported in full in the final scoping review and presented in a PRISMA-ScR flowchart.²³

Once the articles have been deemed eligible for inclusion, data will be extracted by two independent reviewers using a data extraction tool developed by them. The data will include specific details about the population, concept, context, study methods and key findings relevant to the review’s objective. The authors will conduct a pilot test of this tool on four studies to become familiar with the extraction process and results. The data extraction tool will be modified and revised as needed during the data extraction process for each included study. Modifications will be detailed in the full scoping review report. Disagreements arising between reviewers will be resolved through the analysis of a third reviewer. Authors of the articles will be contacted to request missing or additional data, when necessary. Table 1 outlines the preliminary data extraction plan for the study.

Table 1

Data extraction instrument

Study details and characteristics
Title
First author and publication year
Related reference
Country
Study design
Aim/objectives
Sample/participants
Data collection methods
Analysis/main conclusions/content summary
Reviewers’ comments
Results extracted from the studies
Timing of intrauterine device insertion
Type of delivery
Follow-up method (ultrasound, clinical, both)
If ultrasound follow-up:
Interval for the first postpartum ultrasound
Ultrasound periodicity
Ultrasound findings (expulsion, perforation, malpositioning)
Ultrasound parameters qualifying the intrauterine device as poorly positioned
If there is a change in rotation: Which?
Procedure adopted when intrauterine device considered poorly positioned
Symptomatology of patients with poorly positioned intrauterine device
If clinical follow-up:
Interval for the first evaluation
Assessment periodicity
Assessment modality: telephone contact or in-person consultation
Procedure adopted when strings were not visible
Procedure adopted for patients with clinical issues or suspected expulsion/perforation

Critical appraisal of available literature

As the primary aim of this scoping review is to provide an overview of the existing literature, we will not undertake a formal quality assessment of each study. We will, however, assign a ‘level of evidence’ rating to each citation using JBI’s well-established categories.²² This level of analysis will allow for an evaluation of the types of research that has been undertaken in terms of established evidence hierarchies, and to comment on the existing evidence base as a whole.

Presentation of the results

The extracted data will be presented in diagrammatic or tabular form, aligned with the objective of this review. Tables will report the distribution by study type and proposed clinical or ultrasound follow-up, or both, as well as the assessment parameters used in ultrasound to qualify the IUD as well-positioned. The intervals in which the IUD was inserted post partum will also be stratified. A narrative summary will accompany the tabulated results and graphs, describing how the results relate to the review’s objective and question.

Knowledge translation

Throughout the study conduct, we will consult members of a Sexual and Reproductive Health research group; a network led by members of the research team. This group will provide insight and feedback on study findings, help with dissemination of the results and engage in the development of future research proposals. Traditional end-of-grant dissemination activities, including peer-reviewed publications and academic presentations at local, national and international conferences are planned.

Patient and public involvement

Patients or the public were not involved in the design, conduct, reporting or dissemination of our research.

Ethics and dissemination

Throughout data extraction and analysis of the included studies, we will consult with members of a Sexual and Reproductive Health research group working on contraception in vulnerable populations. This group will provide insight and feedback on study findings, help with dissemination of the results and engage in the development of future research proposals. Traditional end of grant dissemination activities, including peer-reviewed publications and academic presentations at local, national and international conferences, are planned. As this is a scoping review protocol, ethics approval is not applicable.

Footnote

Contributors TBH and CdFAA-M contributed to the acquisition, analysis and interpretation of data, writing of the work and final approval of the version to be published. JRBJ and FGS contributed to the conception and design of the study, critical review of the intellectual content of the work and final approval of the version to be published. TBH is the guarantor.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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