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Local current protocol for cervical ripening in 1st trimester miscarriage recommends 400 µg of misoprostol intravaginally 3 hours before uterine evacuation. This regime has been recommended by some international guidelines . So far, there are no recent studies comparing cervical dilatation between 400 µg of misoprostol and a reduced dose (e.g., 200 µg) for 6 hours. If cervical ripening is similar between these two regimens(i.e., 200µg regimen is not inferior to 400µg regimen), costs reductions and lower side effects may be issued without losing quality of cervix dilatation.
Miscarriage is defined by the World Health Organization as the interruption of the pregnancy up to 20-23 weeks, or the products of pregnancy weighing less than 500 grams (1). Nearly 15% of known pregnancies end in miscarriage, especially in the first 12 weeks. Estimates indicate that 68000 women die worldwide each year, as a result of unsafe abortions. Abortions are the major cause of maternal death, particularly in Latin America and the Caribbean. In cases of retained and incomplete abortions, uterine emptying is recommended. In the first trimester of pregnancy, either pharmacological or surgical procedure is accepted according to international guidelines.
Pharmacological treatment for uterine evacuation includes the administration of mifepristone and misoprostol or misoprostol alone. Nevertheless, surgical methods have been shown a greater acceptability and patient satisfaction due to a reduced incidence of adverse effects. Currently, Manual Vacuum Aspiration (MVA) is the technique recommended by the Brazilian Ministry of Health and the Brazilian Federation of Gynecology and Obstetrics.
MVA should be performed after cervical ripening. This pre-surgical procedure makes the procedure safer and more effective. In Brazil, misoprostol is the most suitable drug to be used in these cases because of its efficacy, ease of use, low cost, stability at room temperature, and availability. Misoprostol is a synthetic prostaglandin E1 analog and can be administered by oral, sublingual, buccal, rectal, and vaginal routes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol 400 µg | Active Comparator | Participants received misoprostol 400 µg: 2 tablets of misoprostol (200µg each) introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration (MVA) procedure. |
|
| Misoprostol 200 µg | Experimental | Participants received misoprostol 200 µg: 1 tablet of misoprostol introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol 400mcg Tab | Drug | 400µg of misoprostol (2 tablets) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration | this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration | baseline at initiation of the Manual Vacuum Aspiration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation | This outcome measures how many mm of dilation the cervical canal has before the procedure. Cervical permeability (≥8 mm of dilation, used as a cut-off) was measured using Karman cannulas, from higher to low diameter. | Baseline before Manual Vacuum Aspiration procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score (VAS) | Pain scores were assessed using a verbal analog scale (VAS), ranging from zero (no pain) to 10 (worst possible pain) | before Manual Vacuum Aspiration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo F Ricardo, MD, PhD | HCPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCPA | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20166091 | Background | Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical abortion. Cochrane Database Syst Rev. 2010 Feb 17;2010(2):CD007207. doi: 10.1002/14651858.CD007207.pub2. | |
| 11814515 | Background | Blanchard K, Clark S, Winikoff B, Gaines G, Kabani G, Shannon C. Misoprostol for women's health: a review. Obstet Gynecol. 2002 Feb;99(2):316-32. doi: 10.1016/s0029-7844(01)01701-x. |
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We intend to share raw data with other researchers
unlimited
free to read
A total of 269 were screened. From these, 211 were enrolled and randomized to treatment. After randomization, 2 cases, one case of infected abortion and one case with previous cervical conization were identified and they were treated as for intention to treat.
Participants with diagnosis of miscarriage and scheduled for Manual Vacuum Aspiration at the Gynecologic Emergency Unit of Hospital de Clínicas de Porto Alegre, a tertiary teaching hospital, were recruited. The first participant was enrolled on December 21, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Misoprostol 400µg | Participants received misoprostol 400 µg: 2 tablets of misoprostol (200µg each) were introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure. Misoprostol: 400µg |
| FG001 | Misoprostol 200µg | Participants received misoprostol 200 µg: 1 tablet was introduced into the vagina, at least 6 hours before the Manual Vacuum Aspiration procedure. Misoprostol: 200µg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Misoprostol 400 µg | Misoprostol 400 µg 6 hours before Manual Vacuum Aspiration |
| BG001 | Misoprostol 200 | Misoprostol 200 µg 6 hours before Manual Vacuum Aspiration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Required Cervix Dilation at Initiation of the Manual Vacuum Aspiration | this outcome identifies patients that had to have a mechanical dilator for opening the cervix to perform appropriate Manual Vacuum Aspiration | Intention to Treat Population (all participants assigned to misoprostol 400µg or 200µg) | Posted | Count of Participants | Participants | baseline at initiation of the Manual Vacuum Aspiration |
|
From the MVA procedure until 6 hours after the procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Misoprostol 400 µg | Misoprostol 400 µg 6 hours before MVA | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| uterine hemorrhage | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Grade 2 - medical intervention indicated |
Technical problems with measurement leading to unreliable. Pregnancies with less than 8 weeks had their procedures completely done with small diameter Karman cannulas
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Francalacci Savaris | Dep. of Obstetrics and Gynecology, Universidade Federal do Rio Grande do Sul, Porto Alegre - RS - Brazil | +5551997781966 | rsavaris@hpca.edu.br |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form: English version 2020 NCT02957305 | Jun 28, 2020 | Aug 17, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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Patients, operators and statistical analysis were performed blindly.
| Misoprostol 200mcg Tab | Drug | 200µg of misoprostol (1 tablet) |
|
|
| 25701235 | Background | Marret H, Simon E, Beucher G, Dreyfus M, Gaudineau A, Vayssiere C, Lesavre M, Pluchon M, Winer N, Fernandez H, Aubert J, Bejan-Angoulvant T, Jonville-Bera AP, Clouqueur E, Houfflin-Debarge V, Garrigue A, Pierre F; College national des gynecologues obstetriciens francais. Overview and expert assessment of off-label use of misoprostol in obstetrics and gynaecology: review and report by the College national des gynecologues obstetriciens francais. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:80-4. doi: 10.1016/j.ejogrb.2015.01.018. Epub 2015 Jan 31. |
| 23638497 | Background | National Collaborating Centre for Women's and Children's Health (UK). Ectopic Pregnancy and Miscarriage: Diagnosis and Initial Management in Early Pregnancy of Ectopic Pregnancy and Miscarriage. London: RCOG Press; 2012 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK132775/ |
| 12738178 | Background | ACOG Committee Opinion. American College of Obstetrician and Gynecologist. ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Obstet Gynecol. 2003 May;101(5 Pt 1):1049-50. doi: 10.1016/s0029-7844(03)00396-x. |
| 23433680 | Background | Tang J, Kapp N, Dragoman M, de Souza JP. WHO recommendations for misoprostol use for obstetric and gynecologic indications. Int J Gynaecol Obstet. 2013 May;121(2):186-9. doi: 10.1016/j.ijgo.2012.12.009. Epub 2013 Feb 19. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Obstetric history | Obstetric history was assessed as the median number of previous miscarriages, median number of previous deliveries post 20 weeks gestation (para/parity), median number of previous pregnancies (gesta/gravida) AND median number of previous deliveries before 20 weeks gestation (miscarriages); all of them used the full range | Median | Full Range | cases |
|
| Time from misoprostol to procedure | Mean | Standard Deviation | hours |
|
| Gestational age | weeks of pregnancy | Mean | Standard Deviation | weeks |
|
Misoprostol 200 µg 6 hours before intrauterine suction
Misoprostol 200 µg: evaluate the required cervix dilation in the moment of the intrauterine suction
|
|
|
| Secondary | Number of Participants With a Presence of a Uterine Cervical Canal With ≥8 mm of Dilation | This outcome measures how many mm of dilation the cervical canal has before the procedure. Cervical permeability (≥8 mm of dilation, used as a cut-off) was measured using Karman cannulas, from higher to low diameter. | Intention to Treat (all patients assigned to 400mg or 200µg of misoprostol) | Posted | Count of Participants | Participants | Baseline before Manual Vacuum Aspiration procedure |
|
|
|
| Other Pre-specified | Pain Score (VAS) | Pain scores were assessed using a verbal analog scale (VAS), ranging from zero (no pain) to 10 (worst possible pain) | Posted | Median | Full Range | units on a scale - Verbal Analog Scale | before Manual Vacuum Aspiration |
|
|
|
|
| 106 |
| 0 |
| 106 |
| 1 |
| 106 |
| EG001 | Misoprostol 200 µg | Misoprostol 200 µg 6 hours before MVA | 0 | 105 | 0 | 105 | 3 | 105 |
|
| cervical laceration | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Cervical laceration occurred with Pozzi forceps traction. Local suture was performed without further treatment |
|
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| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |