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Contraception in Women With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02594462
Recruitment Status : Active, not recruiting
First Posted : November 3, 2015
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Escola Bahiana de Medicina e Saude Publica
Information provided by (Responsible Party):
Milena Bastos Brito, MD, PhD, University of Sao Paulo

Brief Summary:
Sickle cell anemia is a homozygous genetic disease with high prevalence in Brazil. There are changes in conformation and physicochemical properties of red cells that generate varied clinical manifestations among which is chronic hemolytic anemia, cardiovascular diseases, fever, splenic sequestration and usually painful crises. Women with sickle cell anemia have high maternal-fetal and neonatal morbidity and mortality. During pregnancy, there is intensification of maternal anemia, episodes of painful crises; and also, more obstetric risks, such as pre-eclampsia, thromboembolism and hemorrhage. Thus, there is the need for adequate reproductive family planning for this population conducted mainly through hormonal contraception. The World Health Organization recommends that all contraceptive methods may be prescribed for people with sickle cell anemia women, being the progestogen-only contraceptive methods the most indicated due to no changes in venous or arterial thrombosis. Nevertheless, there is need for further scientific evidence as the best contraceptive choice among women with sickle cell anemia in relation to safety, adhesion and reduction of pain crises. The objective of this study is to evaluate the clinical effect through safety of etonogestrel-releasing contraceptive implant in women with sickle cell anemia during twelve months.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: etonogestrel-releasing implant contraceptive Phase 4

Detailed Description:

There are 3,500 children born each year with sickle cell disease in Brazil. Almost three percent of Bahia population has sickle cell anemia, which is the most prevalent in Brazil (BRAGA, 2007).

Despite the high prevalence of sickle cell disease in our population, the best option Contraceptive for these women is still uncertain, based on low-quality studies (Haddad et al., 2012). Since this is a condition associated with numerous complications such as painful crises, splenic sequestration, marrow aplasia, among others, leads to frequent hospitalizations and high absenteeism rates. Women with sickle cell disease in reproductive age are exposed to non-planning pregnancies, which will cause high risk for maternal mortality (33%), and increased pictures of painful crises, and important maternal and newborn complications such as abortion, childbirth premature, thrombosis, among others (Andemariam, Browning, 2013). Therefore, there is a need to provide them with appropriate methods for effective reproductive planning.

Hormonal contraceptives with only progestogen, such as releasing implant etonogestrel (ENG), representing an option to reduce unwanted pregnancies, especially in patients at risk for venous thrombosis, such as patients with anemia sickle, because it doens´t interfere with the coagulation system (Conrad et al., 2004; Liedaagard etal., 2011). Thus, in addition to avoid an unwanted pregnancy, these methods have impact on reduction of maternal and fetal morbidity and mortality and neonatal known to be associated with pregnancies in women with sickle cell anemia (Santos et al., 2005).

The scientific literature is limited and scarce on the association between use of methods contraceptives in women with sickle cell disease and correlation with clinical complications such as seizures painful and anemia (Haddad et al., 2012).

The contraceptive implant etonogestrel is a reversibly progestogen-only contraceptive method, long lasting, highly effective, with high continuation rate. However, there is still no studies in women with sickle cell anemia in use thereof.

As it is a progestogen-only method, it does not increase the risk of thrombosis and may, as depot medroxyprogesterone acetate (Abood et al., 1997), reducing painful crises, with the advantage of high efficacy and long duration.

In this context, to increase adherence and whether a clinical benefit from use of the implant contraceptive releasing ENG, the contraceptive method more effectively isolated progestogen available in Brazil, in relation to painful crises and anemia among women with sickle cell disease, it is made of fundamental importance the development of a study in a city of high prevalence in Brazil.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Etonogestrel-releasing Contraceptive Implant in Women With Sickle Cell Disease
Study Start Date : January 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
ENG-group

Twenty-five women with homozygous sickle cell anemia (hemoglobin SS), aged between 18-40 years-old, who had at least one episode of sickle cell pain crisis in the last three months pre- enrollment; whom desire to use etonogestrel-releasing implant contraceptive without contraindications will be invited to inserted etonogestrel implant.

Etonogestrel implant is a single implant progestogen-only, with 4 cm in length and 2 mm diameter containing 68 mg etonogestrel (3- ketodesogestrel), the active metabolite of desogestrel, involved in a ethylene vinyl acetate membrane (Huber, 1998), which is released continuously in bloodstream for three years. It will be inserted subdermal, on the inner face of non-dominant arm between the first and seventh day of the menstrual cycle.

Drug: etonogestrel-releasing implant contraceptive
The etonogestrel implant will be inserted until the fifth day of the menstrual cycle . Anthropometric measurements will be performed , blood pressure measurement , application of pain questionnaire for the last three months, and collection of fasting blood in our clinic . After these measures , the ENG implant will be applied per researcher trained for such a procedure , following the recommendations outlined by the manufacturer. Women are instructed to return after 3, 6, 9, 12 months, fasting 8h , when they will be measured anthropometric measurements , blood collection, and delivery of pain questionnaires and standard of menstrual bleeding.
Other Name: implanon




Primary Outcome Measures :
  1. Number of pain crises [ Time Frame: 12 months ]
    Self reported of pain quantity on a diary.


Secondary Outcome Measures :
  1. Clinical Safety as measured by hemoglobin, hepatic function [ Time Frame: 12 months ]
    Immediately before the implant insertion, peripheral blood samples (20 mL) were collected Blood samples were collected to evaluate complete blood count (reticulocytes, hemoglobin, platelets and leukocytes), hepatic function (Alkaline phosphatase, gamma-glutaryl transferase, amino alanine transferase, aspartate amino transferase, total bilirubin and its fractions), before , 6 and 12 months after the implant insertion.

  2. Pain Scores on the Visual Analog Scale [ Time Frame: 12 months ]
    Pain intensity was measured by a visual scale, scored 0-10 (0=no pain until 10=worst pain) over each 3 months.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women with homozygous sickle cell anemia ( hemoglobin SS ) , who had at least one episode of sickle cell pain crisis in the last three months pre- enrollment.
  2. Age between 18 and 40 years-old ;
  3. Desire to use a long-term hormonal contraception
  4. Agreed to participate in the study after reading and signing the informed consent form.

Exclusion Criteria:

  1. Smoking, alcoholism or drug addiction ;
  2. Obesity , defined as body mass index (BMI ) greater than or equal to 30 kg / m2 ;
  3. contraindication to the use of isolated progestogen , according to WHO's eligibility criteria (WHO 2009)
  4. Desire to maintain standard of cyclic menstrual bleeding ;
  5. Allergy known local anesthetic ( lidocaine ) , once the implant is inserted after subdermal application of the local anesthetic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594462


Locations
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Brazil
Bahiana School of Medicne and Public Health
Salvador, Bahia, Brazil
University of Sao Paulo
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
Sponsors and Collaborators
University of Sao Paulo
Escola Bahiana de Medicina e Saude Publica
Investigators
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Principal Investigator: MILENA B BRITO, MD, PhD University of Sao Paulo

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Responsible Party: Milena Bastos Brito, MD, PhD, Milena Bastos Brito, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02594462     History of Changes
Other Study ID Numbers: 458660
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Milena Bastos Brito, MD, PhD, University of Sao Paulo:
contraception
Anemia, Sickle Cell
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Contraceptive Agents
Etonogestrel
Desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists