Contraception. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. 2014 Apr;89(4):307-13. doi: 10.1016/j.contraception.2013.10.013. The rocky shores at Dalian, the northern coast of the Yellow Sea, along with its cold waters provided excellent growing conditions for these species. Differences in efficacy were pronounced among nulliparous patients. Laminaria have been in use for many years with low risks. Small rods called dilators will be put in your cervix to gently stretch it open. The procedure will usually cause cramping similar to menstrual cramps. Talk with your doctor and family members or friends about deciding to join a study. Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. 2007 Nov;76(5):383-8. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. Laminaria is a type of seaweed that is native to Japan. When inserted into the cervix, laminaria dilators absorb surrounding moisture and gradually swell to a diameter of approximately one-half inch. You will also receive some medications, usually muscle relaxants and pain relief, before the procedure. Your health care provider may numb your cervix so you feel little pain during the procedure. The role and comparison of two techniques of paracervical block for pain relief during suction evacuation for first-trimester pregnancy termination. Laminaria for cervical dilation is used in the form of "tents," usually made of any hygroscopic (readily absorbs water) material, that are placed to maintain the opening or cause dilation. Safe and effective; Less cervical Trauma and pain than with dilator; Preparations. Study design A double blind, randomized, placebo-controlled trial of women at 12–24 weeks gestation one day prior to surgical uterine evacuation procedure. Avoid use. Blanco LJ, Reid PR, King TM. They kept me talking and I could not even feel the laminaria being put in. Individual Participant Data (IPD) Sharing Statement: Pain After Placement of Laminaria (100 mm Visual Analog Scale) [ Time Frame: Measured within 10 seconds after placement of laminaria ], Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) [ Time Frame: 15 minutes post-operatively ], Paracervical or Sham Block Pain [ Time Frame: Within 10 seconds after receiving paracervical or sham block ], Pregnant women between the ages of 18-49 years, Desiring surgical termination of pregnancy or surgical management of a fetal demise, Treatment plan involves cervical preparation with laminaria, Participant able to provide informed consent in English and willing to participate in the study. Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. I felt some pressure but I experienced no pain. The laminaria will stay in your cervix overnight and prepare your body for the next day's surgical procedure. Trials subsequent to the Cochrane review, which included trials up to 2001, have largely found similar results.14 More recent trials have evaluated laminaria versus misoprostol and mifepristone, finding similar efficacy, but showing an increase in cost, induction times, and pain associated with laminaria.15, 16, 17, 18 The lack of blinding remains a methodological issue. Laminaria, a genus of brown algae commonly known as "kelp," is found primarily in the cold waters of the North Atlantic and North Pacific oceans.1. Select one or more newsletters to continue. Likewise, in trials versus prostaglandins, the risk of cesarian delivery was the same for both groups; however, laminaria caused less hyperstimulation with fetal heart rate changes. For later second-trimester abortions, you may also need a shot through your abdomen (belly) before the procedure starts. A large syringe is attached to the tube. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Cervical dilation prior to Dilation and Curettage; Advantages. Because this is a gradual process, the patient rarely notices pain. Rates of cesarian delivery were the same for laminaria versus oxytocin and for laminaria versus extra-amniotic infusion. The first one was barely a pinch, The second was a little more, and the third one hurt only the smallest bit. Women are typically awake for the laminaria insertion. Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Complications of first-trimester abortion: a report of 170,000 cases. Plasma lidocaine levels following paracervical infiltration for aspiration abortion. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Laminaria are placed by a doctor in the clinic. You may be able to get sedation during the abortion. Occasionally the laminaria and sponge may fall out during the night. Contraception. Local Anesthesia: The use of drugs that prevent pain in a part of the body. You may be given pain medication to deal with these cramps. When dried and rounded into a stick-like shape, the dilators are approximately 6 cm (2.5 inches) long with a diameter of 0.3 to 0.5 cm. Afterward, your doctor will insert a dilating stick (osmotic dilator) called laminaria into your cervix. The basal parts of the blades of Laminaria japonica and Laminaria angustata have been used as a hypotensive agent (ne-kombu) in Japanese folk medicine. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Secondary outcomes were mean time required to dilate the cervix, preoperative pain, cervical width, abandonment of the procedure, side effects of dilating agents and duration of surgery. Dilators are made from the dried stems of laminaria seaweeds. Obstet Gynecol. Seaweed stem of 2-3 mm width; String attached to end for removal Hakim-Elahi E, Tovell HM, Burnhill MS. However, with the advent of ethylene oxide and gamma irradiation sterilization techniques, interest in laminaria dilators returned. 2017 Aug;130(2):387-392. doi: 10.1097/AOG.0000000000002149. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Before your abortion, you’ll get pain medicine to help with cramping. Seaweed stem of 2-3 mm width; String attached to end for removal; Swells on contact with water. Adequate pre-procedure cervical dilation reduces D&E morbidity.Mechanical dilationalone is associated with more complications than osmotic dilation with laminaria [20–24]. Helping you find trustworthy answers on Laminaria Insertion | Latest evidence made easy When using a laminaria stick, your doctor will usually insert it vaginally the day before the procedure. Laminaria dilators have been used to dilate the cervix and to induce labor in abortions. Drey EA, Benson LS, Sokoloff A, Steinauer JE, Roy G, Jackson RA. The lack of blinding in these trials must also be considered a potential source of bias.13, In trials of laminaria versus placebo, no evidence exists of increased risk of cesarian delivery. pain score during cervical preparation and after the procedure [ Time Frame: at the time of the insertion, immediately before the abortion and immediately upon recovery from anesthesia ] The pain score will be accessed immediately after the insertion of the laminaria or the vaginal Misoprostol. Laminaria digitata. A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. Soluble and insoluble forms are found in algae.4, 5 Kelp are rich in algin, a high molecular weight polysaccharide that forms viscous colloidal solutions or gels in water. I'm nearly 17 weeks pregnant and due for a surgical abortion, I read that they insert Laminaria sticks into the cervix to soften it but I'm worried about pain, has anyone ever had this procedure or had the sticks inserted? Because this is a gradual process, the patient rarely notices pain. Tents fell into disuse because of complications caused by infections. Available for Android and iOS devices. Cases of hypersensitivity, including anaphylaxis, have also been reported. Kan AS, Ng EH, Ho PC. The placement is described by most patients as “crampy.” We provide pain and anxiety medication to help make the procedure less uncomfortable. To compare pain during laminaria insertion after lidocaine spray versus placebo spray anesthesia in women about to undergo a surgical abortion procedure. The plant is known as kombu in the Far East and is cultivated in China, Korea, and Japan.3, Laminarin (laminaran) is a polysaccharide found in laminaria sap. Laminaria: Slender rods made of natural or synthetic material that expands when they absorbs water; they are inserted into the opening of the cervix to widen it. To detect a 25-mm difference in pain immediately after Laminaria insertion, at an α of 0.05 and 80% power, we aimed to enroll 20 patients in each arm. This surgical procedure requires informed, signed consent and requires a payment. This product may adversely interact with certain health and medical conditions, other prescription and over-the-counter drugs, foods, or other dietary supplements. Obstet Gynecol. You will likely experience cramps if you are not receiving sedation. Thus, the review used risk of cesarian delivery as the comparator outcome measure. You have reached the maximum number of saved studies (100). This product may be unsafe when used before surgery or other medical procedures. There may be slight bleeding, although we place a sponge in the vagina to hold the laminaria in place, and it usually retains any bleeding that might occur. This product has not been reviewed by the FDA to determine whether it is safe or effective and is not subject to the quality standards and safety information collection standards that are applicable to most prescription drugs. Data sources include IBM Watson Micromedex (updated 2 Feb 2021), Cerner Multum™ (updated 3 Feb 2021), ASHP (updated 29 Jan 2021) and others. Information provided by (Responsible Party): To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation. Some women experience cramping or spotting. Epub 2014 Jul 23. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. This allows laminaria to work as a bulk laxative. It also allows laminaria “tents” that have been placed inside the cervix to expand the cervix for procedures or to “ripen” the cervix and speed up the onset of labor . Laminaria contains iodine, an element that the body needs to make thyroid hormones.It is also a rich source of iron and potassium.Despite serious safety concerns about laminaria, some people use laminaria as medicine. The laminaria placement procedure takes 5 minutes. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. At the time of laminaria Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Pre-operative dilation of the cervix with use of osmotic dilators (e.g. While most of the swelling occurs in the first 4 to 6 hours, it may continue for up to 24 hours. Sometimes laminaria (sticks of seaweed for medical use) are placed in the cervix. We comply with the HONcode standard for trustworthy health information -. 2005 Aug;106(2):234-41. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. Paracervical blocks reduce the pain of Laminaria insertion before a second-trimester abortion and increase satisfaction with pain control during the Laminaria insertion procedure. surgical abortion procedure. It is important to fully inform your doctor about the herbal, vitamins, mineral or any other supplements you are taking before any kind of surgery or medical procedure. We calculated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, with 95% confidence intervals ( CIs). Laminaria seems to be able to form a thick, sticky gel when it comes into contact with water. General Anesthesia: The use of drugs that produce a sleep-like state to prevent pain during surgery. Epub 2012 Jun 6. The laminaria absorb fluid from your body and get bigger, which slowly stretches your cervix open. Reports of hypothyroidism exist among Japanese populations, but causality has not been established.27, A case report of laminaria hypersensitivity was followed up with a review conducted through August 2014 of reported cases of hypersensitivity to laminaria. 1990 Jul;76(1):129-35. Of the 10 reactions documented, 8 met the criteria for anaphylaxis. Medically reviewed by Drugs.com. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e. This was especially evident in tents derived from land plants because of the inability of sterilization to inactivate Clostridium spores, the causative agents of tetanus, botulism, and gas gangrene. Scientific Name(s): Laminaria bracteata Ag., Laminaria digitata (L.) Lamour.Common Name(s): Brown algae, Devil's apron, Kelp, Kombu, Lamicel, Laminaria, Ne-kombu, Sea girdles. Please remove one or more studies before adding more. Women assessed their pain on a 100-mm visual analog scale. Many women feel nothing at all. Laminaria digitata. Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial. My nurse helped me get dressed and wipe the blood and got me in a wheel chair. 1984 Apr 27;251(16):2108-11. Information on the use of laminaria for other purposes during pregnancy is lacking. At the same time, the cervix is induced to ripening (becoming soft and flexible). Laminaria arrived in China from Hokkaido, Japan in the late 1920s. Cervical laceration with hemorrhage is one of the most commonly cited serious D&E complications [4,20,25,26]. No deaths in the female patients were reported and most patients experienced prompt resolution with antihistamines and corticosteroids.33. This in turn has myometrial-contracting and cervical-ripening effects.10 Mediation by arachidonic acid has been suggested, but is not supported by evidence.11 Cervical dilation may also be the result of partial placental detachment induced by laminaria.12, A Cochrane review of mechanical methods of labor induction considered trials of laminaria versus placebo, prostaglandins, oxytocin, or extra-amniotic infusion. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. Complications are rare but include infection, breaking off inside the uterus, perforation of the uterus, and an allergic reaction where patients may experience mild generalized itching to a total … Clinical trials are lacking to provide dosing information for uses other than mechanical cervical dilation. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. A strong thread is attached to one end, and a collar prevents migration into the uterus. This property has led to the use of kelp derivatives as bulk laxatives.6 The constituents of laminaria also include iodine, potassium, magnesium, calcium, and iron.7, 8, 9. Mercier RJ, Liberty A. Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. L. bracteata Ag. Preoperative Appointment In a private exam room, you will learn about your procedure, undergo an exam and ultrasound , and receive oral medications that may include a pain reliever and anti-anxiety medication for relaxation, if laminaria is required for overnight dilation. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Keywords provided by Reni Soon, University of Hawaii: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? The effect was attributed to the iodine content of the seaweed. While most of the swelling occurs in the first 4 to 6 hours, it may continue for up to 24 hours. The laminaria is removed. Although laminaria from the ocean harbors relatively nonpathogenic bacteria, polluted waters and poor packaging negated the advantage. With the exception of certain products that are generally recognized as safe in normal quantities, including use of folic acid and prenatal vitamins during pregnancy, this product has not been sufficiently studied to determine whether it is safe to use during pregnancy or nursing or by persons younger than 2 years of age. This information does not endorse this product as safe, effective, or approved for treating any patient or health condition. You should talk with your health care provider for complete information about the risks and benefits of using this product. Epub 2013 Nov 4. Pain scores at laminaria insertion and in post laminaria interval did not differ by age, race, outcome of most recent prior pregnancy, time interval since last pregnancy, number of laminaria inserted or gestational age. Find all the evidence you need on Laminaria Insertion via the Trip Database. This is not usually a problem. The method for inserting a laminaria stick is the same whether you’re inducing labor or having an abortion. Buccal misoprostol plus laminaria for cervical preparation before dilation and evacuation at 21-23 weeks of gestation: a randomized controlled trial. This is a thin rod that is inserted into the cervix and left in place for several hours. There were no significant differences in ability to complete the procedure on the first attempt or patients' intraoperative pain scores. This information should not be used to decide whether or not to take this product. Secondary outcome was self-reported VAS pain score indicating the maximum level of pain experienced during the 24-48hour interval between laminaria insertion and D&E procedure. Last updated on Jan 19, 2021. Your doctor may begin to dilate your cervix by using something called a laminaria stick before surgery. Obstet Gynecol. The stem is hygroscopic and can swell 3 to 5 times its original diameter within 12 to 24 hours. This is only a brief summary of general information about this product. Other natural products used as tents for various purposes include sponges, dried corn stalks, slippery elm bark, and tupelo wood.2 Hollow laminaria tents were developed in the 1800s to improve uterine drainage, and laminaria coated with wax was designed to release antiseptics as the wax melted. The effect is often limited to local cervical ripening; however, stimulation of the cervix can induce labor. 2004 Aug;70(2):159-63. One possible concern is infection. Thank you. Second day insertion of Laminaria has become less common since combining with Misoprostol which allows most pregnancy tissue to be removed on the second day of the abortion procedure. There is a risk of laminaria dilators becoming trapped and fragmenting. Contraception. Endometrial ablation (EA) is a commonly Epub 2007 Oct 4. Indications. This will dilate and soften your cervix, making the procedure as safe as possible. Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied. Once in China, Laminaria was cultivated on a much larger industrial scale. This information relates to an herbal, vitamin, mineral or other dietary supplement. Pain scores during laminaria procedure were slightly higher among participants with no prior vaginal delivery (38 vs 28; p=.07). If you are having a three day procedure, then this placement of laminaria … Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454296. Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion, A sham block will be done prior to the placement of laminaria using a capped needle, A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes. Pre-operative dilation of the cervix with use of osmotic dilators (e.g. They may ask their doctor about a pain-reliever they may use if needed for any discomfort. For an in-clinic abortion, you’ll probably get local anesthesia, meaning that your cervix will be numbed but you’ll be awake. Goldberg AB, Drey EA, Whitaker AK, Kang MS, Meckstroth KR, Darney PD. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Most trials were small and evaluated different outcomes, making comparisons difficult. Laminaria was harvested for food and 1949 yielded 40.3 metric tons of dry weight.  (Clinical Trial), Paracervical Block for Pain Associated With Laminaria Insertion, Active Comparator: Paracervical Block with lidocaine, Reni Soon, Assistant Professor, University of Hawaii. We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. You’ll be awake for the procedure, but can have somebody accompany you if you wish. For general information, Learn About Clinical Studies. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Obstet Gynecol. This is done the day before the procedure to help the cervix dilate slowly. No added benefit was found in trials of laminaria added to prostaglandins or to oxytocin.13. History. This stick absorbs moisture and opens the cervix, as it swells. When inserted into the cervix, laminaria dilators absorb surrounding moisture and gradually swell to a diameter of approximately one-half inch. 1982 Oct;60(4):506-8. Obstet Gynecol. Pain-killers are injected in the cervical area. At the same time, the cervix is induced to ripening (becoming soft and flexible). Read our, ClinicalTrials.gov Identifier: NCT02454296, Interventional U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Laminaria dilators have been used to dilate the cervix and to induce labor in abortions. If you are reading this section you have either undergone an endometrial ablation procedure—or you’re considering one. The vaginal and cervical areas are cleansed. The potential exists for adverse outcomes with laminaria dilator use, especially infectious morbidity; endometritis, fetal sepsis, septic shock, and anaphylaxis have been reported.10, 19, 20, 21 A review of laminaria in cervical ripening found no difference in maternal infection rates for trials reporting infection-related outcomes, but the number of trials was small.22 A further review concluded that serious infection and anaphylaxis were rare with commercial laminaria devices.23 In a review of trials using laminaria in mid-trimester abortions, no increased risk of clinically important subsequent pregnancy complications was found.24, Sulfated polysaccharides from marine Laminaria cichoroides exert anticoagulant activity similar to that of heparin, but clinical relevance is unclear.25, 26, The basal parts of the blades of L. japonica and L. angustata have been used as a hypotensive agent (ne-kombu) in Japanese folk medicine.27 Chemical analysis of the blades suggests that histamine and the amino acid laminine may be responsible for this hypotensive effect.28, 29, Alginate-containing algae reduce the absorption of radioactive strontium in animals and humans and are used in the management of radioactive intoxications.30, There is a risk of laminaria dilators becoming trapped and fragmenting.23, 31 Synthetic laminaria dilators prepared from hydrophilic polymers provide increased levels of structural stability.32, Increases in serum thyrotropin were observed in healthy volunteers who consumed kombu 15 g daily for 7 to 10 days. (L. japonica Aresch) is commonly used in soup, candy, and sushi, or is eaten with rice or as a salad. Contraception. Choosing to participate in a study is an important personal decision. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Cervical softening and dilating is performed with medication and small dilating sticks, called laminaria or Dilapan, that may be placed in the cervix, depending on the gestational age of the pregnancy and your medical history. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Contraception. Laminaria & Pre-Operative Instructions Today you have had one or more laminaria (dilators) placed in the natural opening to the uterus. Once the laminaria stick is inserted, they will pack your vaginal cavity with gauze to help keep the laminaria in place. A sterile tube is inserted into the uterus. Those initial cramps last about 10-15 minutes. Soon R, Tschann M, Salcedo J, Stevens K, Ahn HJ, Kaneshiro B. Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial. May reach up to 5x its original width in 12 hours Physicians rated 27% of the misoprostol procedures as moderate-markedly difficult versus 5% of laminaria procedures (P = .01). Laminaria are thin sticks made from a special seaweed material that widen as they absorb moisture from your body. The mechanism of action may be similar to that of a foreign body that, when inserted into the cervical canal, disturbs the normal chorioamniotic balance and initiates a cascade of prostaglandin synthesis. However, once those cramps disappear there will be other cramps that may begin 1-6 hour later as your cervix dilates. Laminaria has been used traditionally as a hygroscopic cervical dilator and inducer of labor, and commercial products are available for this purpose. This information is not specific medical advice and does not replace information you receive from your health care provider. JAMA. Laminaria are generally safe. Secondary outcomes included assessment of pain at other times during the insertion procedure and overall satisfaction with pain control. Dilation and evaluation (D&E) is the most common technique used for second-trimester abortions. Long-term ingestion (55 to 87 days) led to abnormally elevated serum thyrotropin levels, but these returned to normal on discontinuation of consumption. Data from retrospective studies suggest that cervical Laminaria dilators have been used to dilate the cervix and to induce labor in abortions. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. You also receive a single dose of antibiotics during this visit. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002.