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'Levonorgestrel IUD Insertion After D&E Procedure (ILIAD)

28 marzo 2017 aggiornato da: Heather Hohmann, University of Pittsburgh

Immediate Versus Delayed Insertion of the Levonorgestrel-Releasing Intrauterine Device Following Dilation and Evacuation: A Randomized Controlled Trial

This study is a randomized controlled trial of insertion of the levonorgestrel-releasing intrauterine device (LNG-IUD) immediately following dilation & evacuation (D&E) compared to delayed insertion 3-6 weeks post-D&E. Eighty-eight women undergoing D&E between 15 0/7 and 23 6/7 weeks gestation will be enrolled at Magee-Womens Hospital, Pittsburgh, PA. The primary outcome is LNG-IUD usage six months following enrollment. We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than women receiving delayed insertion. Secondary outcomes include the proportion receiving an IUD, continuation rate, complication rates, subject satisfaction, and quality of life. The utility of ultrasonography in predicting expulsion will also be examined. Anticipated problems include poor subject follow-up and coordinating the intra-operative study procedures.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The D&E will be performed in the usual fashion. The uterus will be sounded to the fundus. Once the D&E is complete, the investigator or co-investigator will check the post-enrollment exclusion criteria to ensure that no events during the D&E made the subject ineligible. If the subject remains eligible, the randomization packet will be opened.

Immediately Post-D&E Procedure.

  1. Group 1: IUD will be placed per study protocol. The strings will be trimmed to be flush with the cervix. Using transabdominal sonography, the distance from the serosal surface of the uterine fundus to the distal tip of the IUD will be measured.
  2. Group 2: No additional procedures will be performed in the operating room.

Post-Operative Care. The subject will then be taken to the recovery room for routine post-operative care.

  1. Group 1: A brief questionnaire will be administered. No additional procedures will be performed in the recovery room.
  2. Group 2: A brief questionnaire will be administered. The subject will be asked to start her previously chosen method of contraception.
  3. Subjects will be asked to call if any temperature exceeds 38°C (100.4°F). If a subject reports a fever (>38°C), an interim visit will be scheduled as described below.

Day 21-42. Post-D&E Visit at 1 month (PAV 1): will be scheduled on a weekday between 8:30 am and 4:30 pm at the time most convenient for the subject. For Group 1, the visit may be on any day from day 21-42. For Group 2, the visit will be scheduled with the goal of inserting the LNG-IUD during the first 7 days of the menstrual cycle.

Subjects will complete a questionnaire about symptoms since the D&E, including pain and bleeding and subjects' history will be collected. Subjects also will complete a set of visual-analog scales about pain, bleeding, and quality of life. All subjects will have a bimanual exam to assess uterine size, cervical motion and adnexal tenderness. Women in Group 1 will have a speculum exam to measure and, if necessary, trim the IUD strings. The length of the segment trimmed will be measured and recorded. If cervicitis or vaginitis is suspected, further evaluation will be performed with diagnosis and treatment by CDC guidelines as indicated. Women in group 2 will have their IUD placed.

Day 56-70: Post-D&E Visit at 2 months (PAV 2): may be scheduled any time within days 56-70 but must be at least 21 days after PAV1. Subjects will complete a questionnaire and visual-analog scales about symptoms since the D&E, including pain, bleeding, and quality of life and subjects' history will be obtained. Bimanual Examination will be performed to assess uterine size, cervical motion and adnexal tenderness. A speculum exam will be done to measure the strings and trim, if necessary. The IUD-Fundal Distance will be assessed by endovaginal sonography.

Day 160-200: Telephone Interview at 6 month (TI 6). A questionnaire will be administered over the phone. Three attempts will be made to contact the subject by telephone. A certified letter with the questionnaire and a postage-paid envelope will be sent if the subject is not contacted.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

93

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15215
        • University of Pittsburgh Center for Family Planning Research

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  1. Gestational age from 15 weeks 0 days to 23 weeks 6 days at enrollment (time of D&E), confirmed by ultrasound
  2. Has already consented to a D&E
  3. Desires to use the LNG-IUD (Mirena) for contraception for 12 months or more
  4. Willing and able to sign an informed consent
  5. Willing to comply with the study protocol
  6. Age greater than or equal to 18 years
  7. Primary residency in Allegheny, Beaver, Washington, Westmoreland, Butler, Armstrong, Indiana, Fayette, Greene, or Lawrence counties of Pennsylvania

Exclusion Criteria:

  1. Allergy to either polyethylene or levonorgestrel
  2. Urgent need for termination of pregnancy (active bleeding or infection)
  3. Exposure to or treatment for gonorrhea or Chlamydia within the past 90 days
  4. Diagnosis of pelvic inflammatory disease within the past year
  5. Presence of one or more leiomyomata greater than 3 centimeters in diameter
  6. Uterine anomaly (other than a repaired septate uterus)
  7. Current participation in any other intervention trial

Post-Enrollment Pre-Randomization Exclusion criteria (to be assessed at the completion of the D&E. These criteria will be used to define a group not eligible for immediate insertion. Since these complications contraindicate immediate insertion, the issue of whether immediate and delayed insertion is preferable is no longer in question.)

  1. Uterine perforation
  2. Hemorrhage as defined by one of the following: (1) need for transfusion; (2) estimated blood loss greater than 500 cc; (3) intrauterine placement of a Foley catheter; or (4) the use of 3 or more doses of uterotonic medications
  3. Evidence of infection at the time of the D&E, including fever (temperature ≥ 38°C) or pus at the cervical os
  4. Subject no longer desires a LNG-IUD

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm I
Levonorgestrel IUD will be inserted immediately after completion of D&E
Droga: Levonorgestrel IUD
intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem
Altri nomi:
  • Mirena
Comparatore attivo: Arm 2
Levonorgestrel IUD will be inserted at standard time post-procedure (3-6 weeks post D&E procedure)
Droga: Levonorgestrel IUD
intrauterine insertion for arm 1 immediately after D&E procedure and for arm 2 at 3-6 weeks post-procedurem
Altri nomi:
  • Mirena

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The Primary Outcome is LNG-IUD Usage Six Months Following Enrollment.
Lasso di tempo: 6 months

To assess the six-month usage rate of the LNG-IUD when placed immediately after D&E compared to 3-6 weeks later, as measured by the proportion of women with a LNG-IUD in place at six months after the D&E.

We hypothesize that more women receiving immediate insertion will be using the LNG-IUD 6 months after the D&E procedure than women receiving delayed insertion.
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To Examine the Number of Women Receiving the LNG-IUD in Each Group
Lasso di tempo: 2 Months
The difference between the overall number of women who had the LNG-IUD inserted immediately post D&E successfully (Arm 1) was compared to the overall number of women who had the LNG-IUD inserted 3 -6 weeks post D&E (standard or routine) (Arm 2).
2 Months
To Compare Expulsion Rates Between Immediate Insertion and Delayed Insertion
Lasso di tempo: 6 months
Compared the expulsion rate of the LNG-IUD in the participants who received the LNG-IUD in the immediate and delayed insertion group
6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Investigatori

  • Investigatore principale: Heather Hohmann, MD, University of Pittsburgh

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2007

Completamento primario (Effettivo)

1 novembre 2009

Completamento dello studio (Effettivo)

1 novembre 2009

Date di iscrizione allo studio

Primo inviato

16 maggio 2007

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2007

Primo Inserito (Stima)

21 maggio 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 marzo 2017

Ultimo verificato

1 marzo 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Pitt IRB PRO06040004

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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