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Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage First-trimester Miscarriage

17 juni 2018 bijgewerkt door: michal roll, Tel-Aviv Sourasky Medical Center

Fertility and Obstetric Outcomes After Medical Management Versus Surgical Treatment for First-trimester Miscarriage

Study Objective: To compare the time to new pregnancy and pregnancy outcomes in women who received Misoprostol for uterus evacuation versus those treated surgically with dilatation and curettage.

Study Population: Women to be admitted to the Lis maternity department for first trimester failed pregnancy. Patients will choose between medical versus surgical management. Of this group, women interested and successful in achieving a new pregnancy without first engaging in birth control methods will be included in our study.

Inclusion Criteria: Women with first trimester failed pregnancy (up until week 12 according to LMP and up to CRL compatible with 11 gestational weeks) Exclusion Criteria: Women under the age of 18 or over the age of 45, women who conceived via fertility treatments, women with a molar pregnancy.

Study Type: prospective study. Study Description: Women who visit the emergency department or gynecology clinic with a first-trimester miscarriage will be questioned regarding their subsequent family planning. In the event that the woman is interested in another pregnancy, and is not planning to use birth control methods prior to conception, the use of folic acid will be recommended, and she will receive an explanation of the research process. Women who agree to participate in the study orally and who sign a written consent form will be included in the study.

Three to six months following uterine evacuation, study participants will receive a telephone call to assess whether they have conceived, and the case that they had not yet conceived, will receive a follow-up call after an additional three to six months.

Each woman who conceived, will receive a follow-up call to assess the details of the birth. In the event that she did not give birth in the Lis Maternity Hospital, she will be asked to fax a copy of the release letter she received from the hospital.

Type of Birth: Normal vaginal delivery, operative delivery, cesarean section. Birth details will be collected via the automated system in Lis in the event that the birth took These women will be included in the study and will be divided into two groups: surgical vs. medical management. The study will include roughly 200 women in each of the two groups.

It will be clarified that:

  1. The researcher will confirm the identity of the participant at the outset of the telephone call.
  2. The researcher will request consent and introduce him or herself as a member of the research team from the Lis Hospital. In the event of refusal to participant, the research will apologize and terminate the telephone call.

Study Parameters: 1 .Demographic Parameters of the two groups - age, gravity, parity, ethnicity, history of infertility.

2. Comparison of the success of the surgical treatment versus medical management - in this case, failure is defined as the need for subsequent surgical treatment. This will include data on the percentage of women who received multiple doses of Misoprostol.

3. A comparison of the time (in months) until a new pregnancy is conceived (from the data of the dilatation and curettage or the first dose of the Misoprostol) 4. Pregnancy Outcomes - first trimester miscarriage, obstetric outcomes, early deliveries, pregnancy complications - IUGR, placental abruption, pre-eclampsia, cesarean sections, neonatal outcomes. This data will be collected in multiple telephone conversations - three months after conception and following the delivery date.

  1. Validation of details of pregnancies that ended in miscarriage - was the pregnancy desired? Mode of conception (if fertility treatments - which?), months until conception, gestational age at the time that a non-viable pregnancy was diagnosed, mode of pregnancy termination. The details will be validated in relation to details in our automated system.
  2. At what month did the woman resume menstruation? Was an ultrasound performed to assess uterine evacuation prior to a new pregnancy conception?
  3. Details on pregnancy following dilatation and curettage - time to conception from pregnancy termination, pregnancy outcomes, gestational age at birth (or miscarriage), birth weight, Apgar scores, pH (if available).
  4. Data on fertility, age, obstetric history, time to conception of new pregnancies, need for fertility treatments.

Mechanism of Anonymity:

The primary researcher will be responsible for the removal of identifying data. After this data has been removed, in the event that it is still necessary to complete data on the participants, we will make contact with the participant and he will sign a telephone consent form regarding this data completion. In the event that no data is mission and/or after the data is completed through a telephone call, the identifying details will be removed in a way that it will be impossible to replace them. And the telephone consent forms will be saved in a cabinet that can be accessed only by the primary and secondary researchers.

Studie Overzicht

Toestand

Onbekend

Studietype

Ingrijpend

Inschrijving (Verwacht)

400

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • Criteria: Women with first trimester failed pregnancy

Exclusion Criteria:

  • Women under the age of 18 or over the age of 45, women who conceived via fertility treatments, women with a molar pregnancy

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: drug treatment
Misoprostol for uterine evacuation
mentioned above
Ander: surgical treatment
dilatation and curettage for uterine evacuation
mentioned above

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Time from evacuation of the uterus to new conception
Tijdsspanne: 2 years
2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
pregnancy outcome
Tijdsspanne: 2 years
abortion/preterm labor/ term labor
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 juni 2018

Primaire voltooiing (Verwacht)

1 juni 2019

Studie voltooiing (Verwacht)

1 juni 2020

Studieregistratiedata

Eerst ingediend

17 juni 2018

Eerst ingediend dat voldeed aan de QC-criteria

17 juni 2018

Eerst geplaatst (Werkelijk)

26 juni 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

17 juni 2018

Laatst geverifieerd

1 april 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 0360-17

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Medisch; Abortus, foetus

3
Abonneren