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Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion

Primary Purpose

Missed Abortion

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
hystroscopy
ultrasound
Aspiration
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- Women in the fertility perioddiagnosed with missed abortion in the first trimester < 14 wks of gestation.

The pregnancy concerned should correspond to a planned or wanted baby. Diagnosis of missed abortion by transvaginal ultrasound showing sgestational sac with no cardiac pulsations.

Exclusion Criteria:

  • • Other type of abortion.

    • Known uterine malformation.
    • History of surgical intervention done in the uterus or uterine cavity.
    • Moderate to sever vaginal bleeding needing rapid surgical intervention.
    • Presence of IUD
    • Current pregnancy obtained by IVF cycle
    • Extrauterine pregnancy

Sites / Locations

  • Kasr Alainy medical schoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

hystroscopy

ultrasound guided aspiration

blind aspiration

Arm Description

The procedure will be performed by a gynecological surgeon, under general anaesthesia with the patient in lithotomy position. Antibiotic prophylaxis may be administered, the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine, depending on the polarity of the resection system.with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. If active bleeding occurs , elective coagulation by hystroscope is done to stop intrauterine bleeding. The deficit of distending media should be calculated at the end of procedure.

The transducer was held on the abdomen to obtain a longitudinal image of the uterus and cervix and provide the surgeon with a visual reference of the gestational sac, cervical canal and any instruments passed into the uterus.The progress of the operation was continuously monitored as the uterine contents were evacuated under visual control. It was possible to keep the dilators and the suction cannula under constant view by slightly tilting the transducer as required. Advancement of any instrument was allowed only under direct ultrasound control.The completeness of the evacuation was confirmed by the scan in these cases.

The women were allowed to empty their urinary bladder before induction of anesthesia, but catheterization was not performed. After positioning the patient appropriately on the operating table, bimanual pelvic examination was performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum forceps. The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The aspirate was examined to confirm the presence of products of conception. The completeness of the evacuation was checked by gentle sharp curettage and final suctioning at the end of procedure.

Outcomes

Primary Outcome Measures

pregnancy rate after evacuation
duration needed to achieve pregnancy after evacuation provided non use of contraceptive methods

Secondary Outcome Measures

Full Information

First Posted
March 10, 2017
Last Updated
April 8, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03081104
Brief Title
Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion
Official Title
Comparative Study Between Operative Hysteroscopy Versus the Ultrasound Guided Vacuum Aspiration Versus the Blind Vacuum Aspiration for the Treatment of the Missed Abortion
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The intervention to be evaluated are operative hysteroscopy(group A) and ultrasound guided aspiration(group C) and blinded vacuum aspiration(group B). For all surgical procedures , surgical antibiotics prophylaxis, misoprostol to dilate cervix, and anti adhesion barrier gel will be used. The evacuated retention products will be sent for pathological examination. Group A: Operative Hystroscopy: The procedure will be performed under general anaesthesia with the patient in lithotomy position. the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine, with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. . Group B:blinded vacuum aspiration of gestational contents: The women were allowed to empty their urinary bladder before induction of anesthesia, After positioning the patient appropriately on the operating table, bimanual pelvic examination was performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum forceps. The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The aspirate was examined to confirm the presence of products of conception. The completeness of the evacuation was checked by gentle sharp curettage and final suctioning at the end of procedure. Group C: Ultrasound guided aspiration curettage : same as group B but guided with ultrasound
Detailed Description
The intervention to be evaluated are operative hysteroscopy(group A) and ultrasound guided aspiration(group C) and blinded vacuum aspiration(group B).these procedures are routinely performed in the obstetrics and gynecology department for various indications. For all surgical procedures , surgical antibiotics prophylaxis, misoprostol to dilate cervix, and anti adhesion barrier gel will be used. The evacuated retention products will be sent for pathological examination. RH negative women will receive prophylaxis to prevent RH alloimmunization. Group A: Operative Hystroscopy: The procedure will be performed by a gynecological surgeon, under general anaesthesia with the patient in lithotomy position. Antibiotic prophylaxis may be administered, the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine, depending on the polarity of the resection system.with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. If active bleeding occurs , elective coagulation by hystroscope is done to stop intrauterine bleeding. The deficit of distending media should be calculated at the end of procedure. Group B:blinded vacuum aspiration of gestational contents: The women were allowed to empty their urinary bladder before induction of anesthesia, but catheterization was not performed. After positioning the patient appropriately on the operating table, bimanual pelvic examination was performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum forceps. The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The aspirate was examined to confirm the presence of products of conception. The completeness of the evacuation was checked by gentle sharp curettage and final suctioning at the end of procedure. Group C: Ultrasound guided aspiration curettage : The transducer was held on the abdomen to obtain a longitudinal image of the uterus and cervix and provide the surgeon with a visual reference of the gestational sac, cervical canal and any instruments passed into the uterus.The progress of the operation was continuously monitored as the uterine contents were evacuated under visual control. It was possible to keep the dilators and the suction cannula under constant view by slightly tilting the transducer as required. Advancement of any instrument was allowed only under direct ultrasound control.The completeness of the evacuation was confirmed by the scan in these cases.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hystroscopy
Arm Type
Active Comparator
Arm Description
The procedure will be performed by a gynecological surgeon, under general anaesthesia with the patient in lithotomy position. Antibiotic prophylaxis may be administered, the cervix is grasped with pozzi forceps and dilated up to hegar 9 to facilitate insertion of the hysteroscopy. The uterine cavity will be distended with saline or glycine, depending on the polarity of the resection system.with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. If active bleeding occurs , elective coagulation by hystroscope is done to stop intrauterine bleeding. The deficit of distending media should be calculated at the end of procedure.
Arm Title
ultrasound guided aspiration
Arm Type
Active Comparator
Arm Description
The transducer was held on the abdomen to obtain a longitudinal image of the uterus and cervix and provide the surgeon with a visual reference of the gestational sac, cervical canal and any instruments passed into the uterus.The progress of the operation was continuously monitored as the uterine contents were evacuated under visual control. It was possible to keep the dilators and the suction cannula under constant view by slightly tilting the transducer as required. Advancement of any instrument was allowed only under direct ultrasound control.The completeness of the evacuation was confirmed by the scan in these cases.
Arm Title
blind aspiration
Arm Type
Active Comparator
Arm Description
The women were allowed to empty their urinary bladder before induction of anesthesia, but catheterization was not performed. After positioning the patient appropriately on the operating table, bimanual pelvic examination was performed under anesthesia to assess the axis and the size of the uterus. A Sim's speculum was inserted into the vagina; the cervix was visualized and grasped using the Vulsellum forceps. The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used. The aspirate was examined to confirm the presence of products of conception. The completeness of the evacuation was checked by gentle sharp curettage and final suctioning at the end of procedure.
Intervention Type
Device
Intervention Name(s)
hystroscopy
Intervention Description
The uterine cavity will be distended with saline or glycine, depending on the polarity of the resection system.with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. If active bleeding occurs , elective coagulation by hystroscope is done to stop intrauterine bleeding. The deficit of distending media should be calculated at the end of procedure.
Intervention Type
Device
Intervention Name(s)
ultrasound
Intervention Description
The transducer was held on the abdomen to obtain a longitudinal image of the uterus and cervix and provide the surgeon with a visual reference of the gestational sac, cervical canal and any instruments passed into the uterus.The progress of the operation was continuously monitored as the uterine contents were evacuated under visual control.
Intervention Type
Procedure
Intervention Name(s)
Aspiration
Intervention Description
The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used.
Primary Outcome Measure Information:
Title
pregnancy rate after evacuation
Description
duration needed to achieve pregnancy after evacuation provided non use of contraceptive methods
Time Frame
12 months after procedure

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Women in the fertility perioddiagnosed with missed abortion in the first trimester < 14 wks of gestation. The pregnancy concerned should correspond to a planned or wanted baby. Diagnosis of missed abortion by transvaginal ultrasound showing sgestational sac with no cardiac pulsations. Exclusion Criteria: • Other type of abortion. Known uterine malformation. History of surgical intervention done in the uterus or uterine cavity. Moderate to sever vaginal bleeding needing rapid surgical intervention. Presence of IUD Current pregnancy obtained by IVF cycle Extrauterine pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hany Saad, MD
Email
hanysaad25280@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35614405
Citation
Meshaal H, Salah E, Fawzy E, Abdel-Rasheed M, Maged A, Saad H. Hysteroscopic management versus ultrasound-guided evacuation for women with first-trimester pregnancy loss, a randomised controlled trial. BMC Womens Health. 2022 May 25;22(1):190. doi: 10.1186/s12905-022-01774-2.
Results Reference
derived

Learn more about this trial

Operative Hysteroscopy and Ultrasound Guided Vacuum Aspiration Versus Blind Vacuum Aspiration for the Treatment of Missed Abortion

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